Quality Assurance Associate

Summary of Duties and Responsibilities

Support the Quality Assurance function in maintaining and continuously improving the company’s Pharmaceutical Quality System (PQS). Assist with ensuring compliance with applicable GMP, FDA, ICH, and other regulatory requirements.

The QA Associate will support the review and management of GMP documentation, quality events, supplier and CMO oversight, training, and other quality activities. The position requires strong attention to detail, good organizational and communication skills, sound judgment, and the ability to work effectively with internal departments and external partners.

Key Responsibilities

Quality System

• Support the implementation and maintenance of the Pharmaceutical Quality System (PQS) in accordance with applicable GMP and regulatory requirements.

Batch Documentation & QA Review

• Review GMP documentation, as assigned, for completeness, accuracy, and compliance with approved procedures.

• Assist with the review of master batch records, executed batch records (EBRs), manufacturing records, packaging records, and related documentation.

• Identify documentation discrepancies, missing information, and potential GMP issues and escalate them to the QA Manager/Director.

• Assist with preparation and review of batch release and product disposition documentation under the direction of QA management.

• Maintain appropriate records related to batch release, rejection, and/or destruction.

Complaints & Other Quality Activities

• Support the administration and tracking of product complaints and quality investigations.

• Support product recall activities, when applicable.

• Assist with preparation of quality-related documents for regulatory submissions, customer audits, and regulatory inspections.

• Perform other QA activities and special projects as assigned by the QA Manager/Director.

• Assist in the preparation, revision, and maintenance of SOPs, policies, forms, and other Quality System documents.

• Support document control activities and ensure that controlled documents are properly maintained and distributed.

• Assist with maintaining GMP records and quality documentation to ensure completeness, accuracy, and traceability.

• Support audit and inspection readiness activities.

• Support deviation inspection tracking, CAPA monitoring and change control.

• Support supplier qualification and ongoing monitoring of suppliers. Support the coordination of supplier and CMO audits. Maintain the records.

• Participate in supplier and CMO meetings as requested by QA management.

• Assist with administration of the GMP training.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, or a related discipline.

• 1–3 years of experience in the pharmaceutical, biotechnology, medical device, or related regulated industry preferred.

• Basic knowledge of GMP requirements, FDA regulations, and ICH guidelines.

• Familiarity with pharmaceutical manufacturing, quality systems, or CMO operations preferred.

• Strong attention to detail and ability to identify discrepancies and potential compliance issues.

• Strong organizational and time-management skills with the ability to manage multiple tasks and deadlines.

• Good written and verbal communication skills.

• Ability to work effectively independently and as part of a cross-functional team.

• Proficient in Microsoft Office applications, including Word and Excel.

• Ability to maintain confidentiality and demonstrate a high level of integrity and professionalism.

• Willingness to travel occasionally, including for supplier/CMO audits, as required.

Pay: $75,000.00 - $90,000.00 per year

Benefits:

• 401(k)

• 401(k) matching

• Dental insurance

• Paid time off

• Retirement plan

• Vision insurance

Work Location: In person