The Quality Assurance Specialist will be responsible for reviewing Operation and Analytical Chemistry department data, reports, protocols, and batch records. Perform release of raw materials, packaging materials, intermediates, and APIs. Maintain tracking and trending of investigations and compliance documents. Interact with cross-functional groups such as R&D, Analytical Chemistry, and Operations to ensure that quality standards and documentation are reviewed in a timely manner, and all standard operating procedures (SOP’s) are followed.

• 5 years or more of relevant experience working in the pharmaceutical industry.
• Minimum BS in chemistry/biology or related scientific discipline preferred.
• Requires thorough knowledge of cGMPs, ICH, and relevant FDA guidelines. CDMO experience is beneficial.

Knowledge / Skills / Abilities:
• Ability to manage multiple assignments and changing priorities.
• Demonstrated understanding of cGMP manufacturing for biopharmaceutical products.
• Strong organizational skills, knowledge of interpretation of analytical data, instrumentation, and electronic data review with emphasis on Empower 3.
• Experience in supporting early phases of API development.
• Efficient in addressing deviations, investigations and corrective actions to ensure compliance and completion within a reasonable period.
• Ability to work under pressure.
• Proficient in Microsoft (Excel, Word, Outlook).

Physical Requirements:
• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in an environment with variable noise levels.
• Ability to stand /sit/walk for extended periods of time.
• Ability to crouch, bend, twist, and reach.
• Clarity of Vision
• Ability to identify and distinguish colors.

Anticipated salary range: $68,442 to $88,679

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

• Supports QA review, approval, and disposition of analytical data for raw materials, starting materials, intermediates, and API release.
• Reviews and approves qualification protocols and reports for equipment.
• Reviews and approves protocols and reports for analytical methods.
• Coordinates Change Control activities associated with validations and commissioning of new equipment.
• Reviews and approves production batch records.
• Reviews and approves equipment cleaning records.
• Performs manufacturing line clearance.
• Release of equipment and rooms for production.
• Authors, revise, review and implement Standard Operating Procedures (SOP), TWI, FOR, REG.
• Reviews and approves quality documents such as deviations, CAPAs, out of specifications (OOX), out of calibrations, and amendments.
• Leads investigations, deviations, and corrective actions to ensure compliance and completion within a specific period.
• Maintains GMP documentation for accuracy, completeness, and compliance to established standards.
• Maintains inspection ready procedures and participate in internal/external audits.
• Participates in opportunities to develop knowledge of cGMP and business operations.
• Collaborate with other functional groups and perform other duties and responsibilities as needed.
• Coordinate and review Environmental Monitoring (EM).
• Review calibration certificates from Operations and QC.
• Keep the QMS well organized in the document control rooms and shared drives.
• Communicate with clients when needed.
• Vendor qualification.
• Assist with the training program.
• Provide support during audits.