QA Associate / QA Associate

Join Our Team as a QA Associate III!

Take the next step in your career and play a pivotal role in upholding top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this is the opportunity you've been waiting for.

Proclinical is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. In this role, you will focus on quality operations and engineering activities related to downstream manufacturing and equipment, ensuring adherence to GMP standards while 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, especially 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 product 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.

If you are interested in this exciting opportunity, please Apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter dedicated to connecting exceptional professionals with outstanding positions around the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

For more information regarding your privacy and how we process and safeguard your data, please visit our privacy policy.