Senior Specialist, QA Operations; Batch Records, Deviations, Control

Job Responsibilities

• Build and maintain cross‑functional relationships to improve processes and resolve issues.
• Provide quality oversight on manufacturing and validation activities.
• Perform real‑time review of manufacturing records.
• Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
• Provide guidance on the handling of quality and shop floor activities.
• Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
• Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
• Identify and report discrepancies from required work practices or procedures to management.
• Use AI tools to enhance individual productivity and quality of work.
• Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

BS/MS degree in a science‑related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred. Minimum of five years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry. Experience working in a GMP aseptic manufacturing environment preferred. Experience working with FDA or other regulatory authorities is preferred.

• Expertise in GMP, quality, material and product disposition.
• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with quality risk management principles.
• Detail‑oriented with demonstrated applications in problem solving and decision‑making abilities with moderate oversight from management.
• Team player who can work independently to achieve objectives in a fast‑paced environment.
• Excellent verbal and written communication skills.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desirable.
• Knowledge of US, EU and rest‑of‑world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Well‑practiced in exercising sound judgment in decision‑making.
• Demonstrated prioritization and organization skills.

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required include close vision and distance vision. This position requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

The employer is an equal opportunity employer and encourages people with disabilities to apply.