Nature and Scope

The Quality Assurance Specialist provides real-time quality oversight and support during manufacturing operations to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal procedures. This position serves as the primary quality representative on the manufacturing floor and is responsible for quality decision-making, batch record review, line clearance verification, aseptic processing oversight, and support of investigations and quality systems.

Essential Duties and Responsibilities

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

• Provide QA oversight during manufacturing and warehouse operations.
• Gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations.
• Perform line clearance activities before manufacturing and packaging operations.
• Perform QA review and release of raw materials, components, and other GMP materials in accordance with approved procedures.
• Conduct routine facility, process, and personnel GMP observations.
• Monitor production schedules and ensure adequate QA support coverage.
• Manage reserve sample inventory, storage, reconciliation, and retention activities.
• Review and approve technical documents including protocol/report.
• Author/Review/approves IQ/OQ/PQ of instruments Protocols and Reports, calibration reports, maintenance reports, OOTN, discrepancy reports, CAPAs, and CCRs as needed.
• Review/approves batch records, logbooks and other related cGMP documents.
• 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.

• Bachelor’s degree in chemistry or biology; or equivalent combination of education and experience.

• 8+ Yrs. experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.

• Broad knowledge of scientific theories, Instrumentation, and analytical techniques.

• Thorough knowledge of GMPs and pharmaceutical products.
• Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations.
• Expertise with writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc.
• Experience in providing high quality deliverables while meeting business needs.
• 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.
• This job operates in a professional office environment.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• A large portion of the work will be performed in the plant where the noise may be loud.
• Gown in support to routinely work at controlled rooms are required.

Expected Salary Range:

$91,000-$101,000

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 candidate’s 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.