Location: Skippers, VA
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary The Stability Associate will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
The role is essential to assure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e. g. Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. Responsibilities of the position include working cross-functionally to establish and maintain the stability program at Civica Petersburg. Responsibilities also include but are not limited to the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program to ensure FDA requirements are met.
Essential Duties and Responsibilities Work across functions to support the development and maintenance of the stability program at Civica Petersburg. Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement. Support the shipment of samples to the appropriate external testing facilities. Work directly with Contract laboratories to coordinate and monitor testing schedules.
Track sample receipt, testing and obtain results and raw data from contract labs. Build and manage stability data in the LIMS system. Supports Annual Product Reviews and Annual Reports for existing products and provides relevant stability reports as needed. Support overall sample management and Quality Control Operations as needed. Compile stability metrics, trend data and report to Management. Ensure that all aspects of the handling, and manufacturing of medical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Practice and promote a safety and quality mindset and a quality excellence approach to all activities. Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions. Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the medical industry. Experience in managing stability studies. Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
Ability to work autonomously within established guidelines, procedures, and practices. Committed to delivering high quality results, overcoming challenges, and focusing on what matters. Continuously looking for opportunities to learn, build skills and share learning. Preferred Qualifications: Experience with Laboratory Information Management Systems (LIMS). Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: This individual has accountability to manage and deliver affordable drug substance, drug product, and API from Civica’s contract development and manufacturing partners (CDMO) in India and Asia Pacific region. The primary role is to actively manage manufacturing, operational, and quality performance according to those agreements during startup, tech transfer, and commercial phases.
For new products and supply nodes, this individual will partner with Civica Business development, Quality, and Executive Leadership to identify and secure agreements with potential partners in the region for biologics, retail, and hospital products, and lead due diligence efforts. As Civica partners increase over time, this individual may be required to staff a small team of consultants/contingent workers to support local quality, engineering, and subject matter experts during intense phases of startup. This may include tech transfer or Health Authority Inspection readiness.
Essential Duties and Responsibilities: For startup phase, act as Civica Operations counterpart to CMO Leadership, and person-in-plant support (PIP) for critical startup activities, always advocating for on time delivery of quality medicines in the best interest of patients and Civica. Facilitate communication of Civica deliverables in support of the Manufacturing Service Agreement such as demand planning. Ensure the CDMO delivers commitments based on Civica Supply Chain planning requirements. Proactively identify risks to supply based upon ongoing trend performance.
These risks can often only be detected through periodic on-site visits. Work with CDMO project management and Civica program management to build tech transfer and startup schedules, and carefully manage schedule adherence. Participate with Civica Supply Chain in Quarterly supplier reviews. For startup sites, work directly with general management and staff to recommend and implement operational improvements. Ensure CDMO is operating within the agreed Quality agreement. Coordinate QA support resources with Civica quality to enable audit and supplier qualification. Prioritize resources at the CDMO, and within Civica to ensure critical products are released in a timely manner.
Ensure CDMO site master plans and major capital upgrades are executed according to agreements and within the best interest of Civica products. Basic Qualifications and Capabilities: 14 years minimum experience, 5 of which should be in a plant operations environment. Experience in Quality and Operations organizations within GMP manufacturing BS/BA level collegiate degree from accredited university Requires up to 50% travel to partner CDMO’s, however time outside of travel can be conducted as remotely-design.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active medical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment. Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas. Replenish manufacturing components, materials, and supplies in all processing areas. Transport bright stock and finished product to and from staging as required according to manufacturing schedule. Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
Clean, set up, and operate component processing equipment. Clean, set up, and operate terminal sterilizer equipment. Clean, set up, and operate weighing and compounding equipment. Weigh APIs and excipients according to batch record instructions. Compound bulk drug product per standard operating procedures and batch record instructions. Clean, set up, and operate packaging equipment. Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices. Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Perform other duties as assigned by manufacturing management. Minimum Qualifications (Knowledge, Skills, and Abilities) • High school diploma or equivalent. Coursework or bachelor’s degree in a Life Science discipline preferred. • 2-3 years’ experience in medical manufacturing environment preferred. • Good reading and writing skills, and ability to perform basic to advanced mathematical calculations. • Ability to read, understand and follow written procedures.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Head of Quality Systems leads the deployment and improvement of the Quality Management System (QMS) at Civica that ensures a high state of c GMP compliance and supports the effective execution of Civica objectives, including lifecycle management of policies and procedures for processes that govern all Gx P related activities.
Also, leads the following quality management systems: Documentation, Change Management, Investigation/Deviation and CAPA, Complaints, IT Quality, and Training. Additionally, is the owner of Electronic Systems associated with Documentation Management, Deviations/CAPA Management, Change Management and Learning Management. Essential Duties and Responsibilities: Establish, and maintain the global QMS elements including policies, processes, procedures and controls, enabling successful and efficient development and manufacturing of drug products meeting Civica and regulatory requirements.
Establish and maintain risk-based, fit-for-purpose Quality Management System. Oversee the pharmacovigilance program ensuring robust reporting and investigations. Responsible for the electronic quality management system (VEEVA) and ensuring the system maintains its validated state. Develop robust systems to assure corrective and preventive measures are systematically implemented and controlled. Propose and drive continuous improvements to the Quality Management System to streamline business processes and stay in compliance with external requirements (e. g. regulatory). Design and maintain trending program for quality events/ laboratory controls/ production controls by key indicators (e.
g. dates, categories, root causes, and CAPA) to identify adverse trends/ risk to help drive continuous improvement for manufacturing/ production controls and laboratory controls per Civica Gx P procedures. Ensure Computer System Validation (CSV) processes are fully implemented with the appropriate quality oversight. Develop and implement Medical Device Reporting (MDR) processes for combination products. Support and ensure the governance of any other initiatives as delegated. Establish and maintain Quality Plan.
Basic Qualifications and Capabilities: Minimum 15 years of life science/medical/biologics product manufacturing and development experience. Bachelor’s degree in a science, shop, or engineering discipline. Advanced degree desired. Broad knowledge and experience with quality assurance and quality system, regulatory compliance and understanding of current regulatory requirements and trends for manufacturing drug substance, drug product and combination products, in particular sterile injectable medications. Prior experience managing personnel. Working knowledge of software solutions for QMS.
Strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment. Strong project management skills with an emphasis on critical thinking and problem solving. Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance. Extensive experience in hosting FDA inspections, keeping pace with ongoing updated regulations and requirements, and as applicable especially 21CFR211, 21CFR820/803/806.
Brief Description of Duties Be the principal point of contact for graduates and former enrollees during transition, placement and follow-up as appropriate. Initiate transitional support referrals to off-center placement specialists and other community agencies.
Contact employers and one-stop centers to arrange for interviews and other activities to promote initial placement. Make regular contact with former students during the placement and follow-up period; provide services as needed; document in the automated case management system. Verify, document and report placements meeting PRH requirements using the automated system and ETA-678. Maintain regular contact with career development
specialists and career technical training instructors on center. Work closely with department staff to gather information and maintain open communication with workforce development centers throughout the state (in which the center is operating).
Produce and distribute placement and follow-up reports. Assists in the continued implementation of the Center’s Career Success Standards program. Works towards meeting performance standard goals. Follows CDSS plan and Code of Conduct system daily. Maintains good housekeeping in all areas and complies with safety practices. Complies with all DOL guidelines, OFCCP regulation, Quality Assurance Plan (QAP), Serrato policies and procedures, Job Corps
notices and bulletins, and Center policies and procedures. Demonstrates and abides by Serrato Corporation’s core values and operating principles.
Models, mentors, monitors appropriate Career Success Standards. Helps students become more employable through continuous reinforcement. Participates in PRH mandated staff training. Failure to participate may result in disciplinary action up to and including termination. Performs other duties as assigned. Key Competencies Performance Standards/Results Effective Communication Presents information both clearly and concisely and regularly confirms correct interpretation of information. Very high standard of communication skills both written and verbal for the presentation of facts and ideas.
Shows professional non-verbal body language and actively listens to others. Organization of Work Action oriented. Demonstrates the ability to handle several projects simultaneously with decision making, flexibility, and problem solving. Implements the key principles of time management, task allocation and priority assignment in addition to personal organization. Shows attention to detail and ability to complete work with the highest level of accuracy and efficiency. Continually seek ways to improve employment service provided via development of professional skills and personal growth.
Professionalism Demonstrates professional interpersonal skills when interacting with others. Abides by Serrato Corporation's Healthy Workplace Environment Policy. Acts as a team player and builds professional relationships with coworkers to achieve goals. Leadership & Management Ability to exceptionally manage and lead students from diverse backgrounds. Committed to investing in and developing students and positioning them to succeed. Mission-oriented and possesses a strategic vision. Motivates students and provides coaching and/or feedback when needed.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Proficiency with Microsoft Office applications including Word, Power Point, Outlook, and Excel. Ability to effective assists students in career choices. High level of communication, interpersonal, analytical, and organizational skills. High level of ability to motivate and inspire students effectively. Knowledge of local career and technical education opportunities. Experience Two years’ related experience. Education Bachelor’s degree in human services, psychology, counseling, education, social science, business, communications, or closely related field; or Associate’s degree in human services, psychology, counseling, education, social science, business, communications, or closely related field, and two years related experience.
Certificates, Licenses, Registrations Valid State Driver’s License. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, and walk; to reach with hands, arms, talk, and listen. The employee is occasionally required to sit; to use hands and fingers to handle or feel; to taste and to smell. The employee must be able to occasionally lift and/or move up to 40 pounds. Specific vision capabilities required by this job include close vision, distance vision, and peripheral vision. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to outdoor weather conditions. The noise level can vary from moderate to loud. Benefits Offered Paid Short Term / Long Term Disability and basic life insurance. Health care insurance available (medical, dental, vision, critical illness, accident, HSA, and FSA) Paid Holidays Paid Time Off 401K & 401K Matching Tuition Reimbursement Employee Assistance Counseling Service Program Disclaimers Serrato Corporation is an Equal Opportunity Employer Serrato Corporation conducts background checks and drug screens.
you’ve been searching for! If you love providing care for animals, are independent, dedicated, and trustworthy with high personal standards, then we’d love to meet you! WHO WE ARE: Fetch! is a leading neighborhood provider of professional dog walking and pet-sitting services in the DMV for over 10 years.
We are currently expanding our team in the all our markets, seeking dedicated and trustworthy individuals to perform pet sitting and dog walking services in the following locations: Alexandria, Arlington, Falls Church, Mc Lean and Washington, DC. AVAILABLE POSITIONS: Dog Walkers Pet Sitters · Mid-Day Shift (Consistent availability for a minimum of 2 hours between 10AM and 4PM) A POTENTIAL
PURRFECT FIT FOR: · Retirees· Stay-at-Home Parents· Military Spouses· College Students· Veterinary Care Professionals· Remote & Freelance Workers IDEAL CANDIDATE (Obviously loves animals!
) · Experienced in caring for pets (friends and family experience counts! )· Friendly, creative and customer service oriented· Able to lift 20-50 lbs and walk between 1-5 miles daily· Able to learn quickly, work independently and adapt easily· Able to communicate clearly and effectively· Able to follow directions, manage time and organize a schedule· Able to navigate internet, email and apps via computer and smartphone· Willing to commit to at least 6 months JOB REQUIREMENTS: · Be at least 21 years of
age or older· Live in or near the area(s) which we service· Have a vehicle (registered and insured)· Have a smartphone HOW TO APPLY: Visit the website below and complete the application online/r/FPCPCP21
& digital) at a creative agency. Must have recent magazine publications experience. Must have proven experience in art direction. Prior experience working on long-form design with the editorial team. Expertise in Adobe Creative Cloud Suite and Figma.
Agency background. Bachelor's Degree in Graphic Design or similar field. Graphic Designer Responsibilities: Continuously deliver high-quality work while adhering to brand standards and guidelines within tight timelines and budget. Design print & digital publications, existing and from scratch. Create original concepts across social, video, print, and digital and see projects through completion. Design various marketing collateral
such as brochures, presentations, social assets, banners, web pages, publications, and others. Play essential role in the conceptualization of omnichannel design deliverables.
About Profiles An award-winning creative and marketing workforce solutions provider. Profiles places the highest caliber candidates in Fortune 500 companies and leading brands, nationwide. Our specialized recruiters represent an elite group of skilled professionals for contract, contract-to-hire, and direct hire positions. Profiles is headquartered in Baltimore, MD with a remote staff of entrepreneurial individuals across the nation. New job opportunities are listed daily -.
