QA Associate

Integrated Downstream Quality Operations Role

Join a large-scale manufacturing facility to play a key role in maintaining top-tier quality standards. This position focuses on quality operations and engineering activities related to downstream manufacturing and equipment, ensuring compliance with GMP standards and supporting the production of safe, effective, and high-quality products.

Key Responsibilities

• Perform QA activities for downstream operations, GMP manufacturing, and equipment to ensure product safety, efficacy, and purity.
• Review and approve GMP engineering and manufacturing documents, including procedures, work instructions, CAPAs, deviations, change controls, equipment work orders, P&IDs, qualification protocols, and calibration deviations.
• Collaborate with cross-functional teams, including Manufacturing, Manufacturing Sciences, Process Engineering, and Automation SMEs, during deviation management and investigations.
• Participate in monitoring and release activities for column packing/unpacking and chromatography processes.
• Ensure adherence to internal procedures during downstream manufacturing operations and equipment controls, particularly during GMP CAPEX and OPEX projects such as shutdowns, construction, or new product introductions.
• Take part in the Quality On-Call duty rotation.
• Contribute to batch record review and closure in preparation for batch release.

Key Skills and Requirements

• Strong understanding of GMP standards and downstream manufacturing processes.
• Experience with quality assurance activities, including document review, deviation management, and equipment qualification.
• Ability to collaborate effectively with cross-functional teams.
• Familiarity with electronic batch records and quality systems is a plus.
• Detail-oriented with strong problem-solving and analytical skills.
• Willingness to participate in on-call rotations as needed.