Quality Assurance Specialist

Job Description

Duties & Responsibilities:

• Support QA oversight of externally manufactured finished goods, including packaging, labeling, and assembly operations.
• Perform executed batch record review, including associated documentation, for completeness, accuracy, and compliance with approved procedures and GMP requirements.
• Support external deviations, investigations, and change controls, including review, tracking, and associated quality system activities.
• Create and revise finished goods specifications, SOPs, work instructions, and other controlled documents.
• Identify and escalate documentation discrepancies, quality concerns, and potential compliance issues to appropriate QA personnel.
• Collaborate with Manufacturing, Supply Chain, Regulatory, and other cross-functional partners to support quality activities.
• Support continuous improvement of QA processes, documentation, tracking tools, and systems.

Required Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) or equivalent of education and experience.
• 1–3 years of experience in Quality Assurance or Quality Operations within the pharmaceutical, biotechnology, or medical device industry.
• Experience with finished goods manufacturing, packaging/labeling, or external manufacturing preferred.
• Working knowledge of cGMP requirements and pharmaceutical quality systems.
• Experience reviewing executed batch records and associated GMP documentation preferred.
• Experience supporting deviations, investigations, and change controls, including familiarity with root cause, impact assessments, and corrective actions.
• Familiarity with specifications, SOPs, and other controlled documentation.
• Experience with electronic Quality Management Systems (eQMS) and document management systems.
• Strong attention to detail with the ability to identify documentation discrepancies and potential quality issues.
• Strong written and verbal communication skills.
• Ability to manage multiple assigned activities, prioritize work, meet deadlines, and proactively communicate risks or delays.