QA Associate
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What you'll do
- 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.
What they're looking for
- 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.
- Detail-oriented with strong problem-solving and analytical skills.
- Willingness to participate in on-call rotations as needed.
Nice to have
- Familiarity with electronic batch records and quality systems.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.
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. This position involves ensuring compliance with GMP standards and supporting the production of safe, effective, and high-quality products.
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.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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