Senior Quality Assurance Specialist

Nature and Scope

Under the supervision of the Director of Quality Assurance this position is responsible for batch release for commercial product to the market. This position supports the activities and initiatives to implement and manage the Quality System.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Reviews batch records and oversees the process to release batches from quality hold and provide Certificate of Conformance.
• Review batch release from Contract manufacturing operations (CMO) and perform final batch release to commercial market.
• Communicate and resolve issues with CMOs.
• Manage and support customer and/or regulatory audits inspections and the site responses.
• Follow up and finalize regulatory and client audit responses and ensure the completion of the CAPA.
• Perform site wide routine inspection readiness training.
• Monitor the production schedule and ensure adequate line coverage support from QA.
• Evaluate analytes and trends quality key performance indicators. Develop and manage key performance indicators and metrics to present to the leadership team.
• Review Quality agreement and finalize Quality agreement and PV agreement with supplier vendor and client.
• Facilitate manufacturing deviations and investigations.
• Support FDA field Alert.
• Perform customer complaint investigation.
• Review and approve protocol and report as assigned.
• Support change control for operation department.
• Participate and support in internal/external audits.
• Author review and approve Standard Operating procedures.
• Other quality assurance duties as assigned and required to meet relevant 21 CFR Part 210 and 211.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Bachelors degree in chemistry or biology; or equivalent combination of education and experience.
• 10 years of related manufacturing and quality assurance in the pharmaceutical industry.
• Broad knowledge of scientific theories instrumentation and techniques.
• Thorough knowledge of GMPs GLPs and pharmaceutical products.
• Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations
• Must be able to read documents in Standard English such as Standard Operating Procedures maintenance schedules and operating manuals.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment including but not limited to gowning goggles face shields respirators and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Salary Range:

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The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications education knowledge skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare life insurance profit sharing paid time off matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

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