skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Summary This is a leadership role that is responsible for a team of Quality Operations Specialist, which will require providing oversight of quality documentation and operations in adherence to c GMPs and SOP regulations.
QOps Supervisors will represent Quality at cross-functional meetings, providing Quality input and decision making in Quality events and deviations. They will provide training to group and departments when needed. Coordinate review of manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks,
Quality Control (QC) testing reports, environmental monitoring reports, etc. Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion Create, review and approve documents in Master Control Serve as QOps representative for client project teams as assigned by management Coordinate performance of key QOps functions by team members, including line clearances, general manufacturing support, product shipment, raw material receipt and release, etc.
Participate in departmental and cross-functional continuous improvement efforts Train and mentor assigned QOps Specialists and Leads Promote a safety mindset through daily
actions and communication with team members Manage risk and escalate issues to QOps management in a timely manner Communicate professionally, effectively, , and efficiently with all clients, internal and external Job Qualifications Bachelors degree in a life science or related field preferred Minimum of 5 year GMP related experience in biomedical/medical or related industry or a combination of 5 years of education and related work experience required Experience with GMP regulatory requirements The pay range for this position is $74,700 - 83,500 annually.
Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
Compensation Data About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and medical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products.
Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety backssment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.
Our client base includes global medical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.
We have proudly supported the development of 86% of the drugs approved by the FDA in 2021. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to xyz X@.
This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit.
and guides the implementation of new processes, procedures, and methods. Models appropriate behavior as exemplified in MLH Mission, Vision and Values. Education/Experience/Licensure Education/Formal Training Work Experience Credential/Licensure REQUIRED: Associates degree in Nursing Minimum of three years experience as a registered nurse with at least two years experience providing direct patient care in a home health or hospice program.
Current licensure as Registered nurse in state of Tennessee or compact license. PREFERRED: Bachelor’s degree in Nursing N/A N/A SUBSTITUTIONS ALLOWED: N/A N/A N/A Knowledge/Skills/Abilities Must be qualified by knowledge and experience to oversee the
services provided in the assigned department/business unit. Demonstrates knowledge of federal, state, and local regulations and industry standards related to patient care services provided.
Strong professional, organizational, and interpersonal skills required for effective and creative leadership in working with all levels of the organization. Ability to lead and motivate individuals and groups toward the accomplishment of organizational goals. Possesses good analytical and problem solving skills. Demonstrates a high level of organizational skills to establish and manage priorities and maintain follow-up. Demonstrates initiative, flexibility, integrity and diplomacy. Proficient in the
use of Microsoft applications (such as Word, Excel) and experience with database systems.
Ability to apply critical thinking skills to identify problems, research alternatives, and recommend solutions. Working knowledge of healthcare reimbursement or experience in a similar healthcare administrative role is preferred. Work will require ability to read, interpret, and apply regulatory guidelines. Key Job Responsibilities Regulatory/Accreditation Readiness Responsible for the coordination of accreditation and regulatory standards for the assigned area(s)/business unit. Establishes and implements processes to support ongoing compliance and survey readiness.
Collaborates with leadership and team members to meet accreditation and compliance goals and objectives. Coordinates compliance audits, survey visits/activities, and post-survey follow-up activities. Serves as a change agent to identify, report, and recommend opportunities for improvement in clinical processes and procedures. Reviews proposed clinical processes and/or practices to determine implications and whether a new/revised standard is practical or achievable. Evaluates availability and capability of resources and identifies barriers required to fulfill clinical practice standards. Guides and coordinates policy/practice review to ensure alignment with regulatory and accrediting standards, best practices, and evidence-based practice.
Medical Record Review & Data Reporting Performs supervisory review of patient backssment forms completed by the clinicians for compliance with payor and regulatory data elements. Ensures documentation is valid, complete, and consistent with these requirements. Monitors patient’s plan of care to ensure sufficient medical documentation meeting payor and regulatory guidelines. Researches and resolves problems that may impact reimbursement for services.
Collects and reports backssment data and plan-of-care documentation electronically to a centralized state data repository. Serve as primary contact with physicians/physician offices to collect clinical documentation consistent with regulatory and reimbursement guidelines. Stays current in CHAP, Medicare, State, and other payor and regulatory requirements related to services provided. Assists with evaluating the quality of care provided by comparing performance with national benchmarks; collaborates with the Director of Quality in the identification, implementation, action planning, and tracking of improvement activities.
Clinical Education Develops, delivers, or coordinates standardized clinical education programs to meet existing, new, and revised patient care standards, processes, and regulatory guidelines. Guides the implementation of new processes, procedures, and methods. Educates clinicians on appropriate documentation protocols for data collection and documentation. backsses and maintains documentation of staff training and competencies; conducts regular review of continuing education, licensure, and certifications to ensure qualifications are maintained. Supervisory Supervises staff members as assigned within the department.
Monitors Associate performance and clarifies work expectations, and assists with goal setting; promotes cooperation among individuals and groups. Develops and implements processes through orientation, training and education to ensure that the competence of all staff members is backssed, maintained, improved and demonstrated throughout their employment. Plans and schedules work ensuring distribution of assignments and adequate staffing based on workload and productivity standards. Physical Requirements The physical activities of this position may include climbing, pushing, standing, hearing, walking, reaching, grasping, kneeling, stooping, and repetitive motion.
Must have good balance and coordination. The physical requirements of this position are: light work - exerting up to 25 lbs. of force occasionally and/or up to 10 lbs. of force frequently. The Associate is required to have close visual acuity to perform an activity, such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; or extensive reading. The conditions to which the Associate will be subject in this position: The Associate is not substantially exposed to adverse environmental conditions; job functions are typically performed under conditions such as those found in general office or administrative work.
