is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality Assurance
Specialist is responsible for the quality assurance functions at Catalent, Madison. The position primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements by developing and implementing quality assurance policies.
This includes Identifying production, process, or product issues, documentation management, internal and external auditing, interfacing with clients and managing client quality relationship. Quality Assurance Specialist involves serving as the main point of contact for designated projects, collaborating both internally and externally across different functions. This includes aiding in the integration
of the client's program into Catalent quality management system and ensuring successful management of client expectations.
This is a full-time on-site salaried position, Monday - Friday, 8:00am to 5:00pm CST Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of production Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports Accountable for review and approval of project related deviation investigation records Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 0 years related experience OR Master's degree in STEM discipline with minimum of 4 years related experience OR Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR Associates Degree in STEM discipline with minimum of 10 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to xyz X@. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U. S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U. S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. This
position requires a variety of skills necessary for biotech company operations. Perform technical quality data review of stability, release, and in-process manufacturing samples for a large variety of testings, including but not limited to, Appearance, p H, Osmo, SEC, IEX, CE, c IEF, ELISA, and SDS-PAGE, while adhering to SOPs and working in a c GMP compliant environment.
This position will be required to understand the intricacies of testing types to provide a high quality of technical review. Other duties may include database entry/review of data and data packets and contributions to process improvement initiatives. This is a full-time on-site salaried position, Monday - Friday 9:00am
to 5:00pm Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role: Independently performs quality data review of c GMP records. Authors technical documents such as SOPs and reports. Coordinates with Supervisor to prioritize and schedule activities to meet deadlines. Supports continuous process improvement initiatives. Interacts as an SME for internal and external customers. Supports training of specific analytical techniques. Actively participates in team meetings and/or training sessions. All other duties as assigned The Candidate: Requires Ph.
D. Degree in Biology, Biotechnology, Chemistry or related life sciences field OR Master's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience OR Bachelor's Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience OR Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience OR High School Diploma or equivalent with a minimum of 11 years of industry experience Intermediate to advanced proficiency in MS Office preferred Familiarity with EMPOWER software preferred Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to xyz X@.
This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U. S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U. S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
Projects has been executing successful healthcare design/build projects since 1994. We strive to uphold our standard of excellence in delivering complex healthcare projects on schedule, on budget and with complete customer satisfaction, and we demonstrate our commitment to these goals by submitting to third party performance reviews on every completed project.
More than 20 years later, we continue to expand our client centric, performance driven, healthcare design/build efficiency model. The measured steps in our growth have presented many new exciting opportunities as our clients engage us on larger, more constrained healthcare projects. SUMMARY & PURPOSE OF POSITION: This position is
directly responsible and has the direct oversight for the Company's Quality Control Management program and safety program including onsite safety. This person ensures the quality of the workmanship through implementation of the three phases of quality control as well as ensuring all personnel working on the project, including vendors, are following safety standards and protocols according to OSHA, the company's and the client's standards.
RESPONSIBILITIES & TASKS: A firm understanding of the three phases of control and the submittal process. Compile and complete work plan books, submittals and project close out documents Chair and document weekly QC meetings and provide written minutes
as described in project specific contract documents Coordinate and document the testing and commissioning of building systems as well as understand testing procedures Verify and document that all materials received for the project are in conformance with the approved submittal, are handled and stored appropriately and are acceptable for use in the project Effectively communicate the standards of care required for each definable feature of work to the various team members in the project through the use preparatory, initial, follow-up and other less formal meetings Schedule, document the results of, and maintain a log of all code and independent inspections that are required Participate in regularly held meetings involving internal staff and external stake holders, such as Owners, Subcontractors, etc.
attend meetings and act as the main liaison with the client for all safety matters In coordination with others in Project Management, review shop drawings and submittals for conformance with project drawings, specifications and change directives Maintain Quality Control and adhere to sequential cycle of the project Responsible for ensuring compliance with the safety program, both the EM 385 & Company Safety Program. This includes all personnel working on the projects under our contract, including subcontractors Adhere to all Federal and State safety requirements, problem solves any issues Address and eliminate any safety hazards Prepare and implement an effective safety & health program Oversee and Enforce Infection Control & Risk backssment plans and mediation Complete all documents, reports and other administrative assignments as it relates to safety Assist the Superintendent as necessary Handle any on the job accidents and follow the legal & proper reporting procedures Ensure all workers and subcontractors adhere to the safety / infection control policies and protocols on the job sites SKILLS, ABILITIES, EXPERIENCE REQUIRED & PREFERRED: Bachelor's Degree in Construction Management or related degree or 7 years minimum of construction safety experience Minimum of 5 years of experience as a Safety Engineer for a General Contractor Medical project experience required as a Safety Engineer, medical government experience preferred Current CQM certification Effectively manage safety on job sites with few minor violations Demonstrates knowledge of quality control practices and is efficient in the processes Correctly utilizes IDBO software and RMS systems according to the company procedures Accurately records all incidents and follows safety and workers compensation protocol; maintains proper organization of all safety concerns and incidents Meets the clients standards with safety with few complaints from the owner Must be thoroughly familiar with EM 385 Manual & Infection Control Requirements Demonstrates a thorough understanding of Federal and State safety requirements OSHA 30 and EM 385 training completed May be asked to travel approximately 25% of job ASHE Infection control training or ability to obtain training; demonstrates strong knowledge of infection control and the project abides by these procedures CPR and First Aid Certified PHYSICAL & ENVIRONMENTAL REQUIREMENTS: Ability to navigate through a construction site for extended periods Ability to work on a computer and perform administrative tasks Ability to perform moderate physical work such as climbing, lifting, stooping, using construction tools, moving boxes, and lifting up to 40 pounds.
Ability to communicate in person, phone and electronically by hearing and talking Depending on project location, employee is subject to infectious diseases from patients in hospitals Subject to close quarters, small enclosed rooms and narrow passageways Must be able to stoop, grasp objects, walk for long periods of time, stand for long periods of time, and climb ladders, balance, push, pull and lift.
Subject to changes of environmental conditions both outside and inside; Subject to noise and vibrations; Subject to hazards; Subject to working in hazards, including electrical currents, mechanical parts, fumes, odors, dust, gases and poor ventilation. We are an Equal Opportunity Employer. We are committed to providing equal opportunity in all employment activities without regard to race, color, religion, interaction, national origin, interactionual orientation, gender identity, disability, pregnancy, marital status or protected veteran status.
Minority/Female/Disability/Veteran Job Posted by Applicant Pro
is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality &
Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
The Quality & Compliance Senior Specialist I works closely with c GMP groups throughout the facility in order to perform internal audits, and to client audits and regulatory inspections. The Senior Specialist I also works directly with clients to support audits and inspections, as well as to develop process validation documents to support the client project moving from clinical to commercial. The Quality & Compliance team is responsible for ensuring the site remains regulatorily compliant and always inspection
ready. This is a full-time on-site salaried position, Monday - Friday 8:00am to 5:00pm Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role: Oversees the internal audit program, including coordinating the audit with relevant department subject matter experts, performing in-depth backssments of systems and procedures; communicating audit findings to key stakeholders; assisting with the development and review of audit responses Oversees the customer audit program, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions Monitors and backsses changes to regulatory guidance and compendial monographs Provides support to ensure that the quality systems are maintained in compliance with regulatory and customer requirements as well as corporate requirements.
Supports and enhances effectiveness of the quality system, including developing and reporting metrics; developing and authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Drafts, reviews, executes, and approves technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.
g. PPQ, CPV, APR / PQR) All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 7 years related experience, OR Master's Degree in STEM discipline with minimum of 10 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 15 years related experience, OR Associate's Degree in STEM discipline with minimum of 17 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to xyz X@.
This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U. S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U. S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
