Quality Operations Compliance Specialist
Summary:
Ensure that all products and manufacturing processes meet required quality standards for both commercial and investigational drug products. Provide compliance oversight and support to Operations to ensure adherence to GMP and internal procedures.
Key Responsibilities
- Lead or assist with investigations into product or process non-compliance.
- Review and audit completed batch records and manufacturing logs.
- Perform quality checks on operational documentation (e.g., SOPs, work instructions, risk assessments).
- Conduct incoming raw material checks and maintain product status as required.
- Support stability program activities (e.g., sample pulls, protocol generation, weekly checks).
- Administer quality logs (e.g., QA Hold, Sample Requests).
- Lead daily compliance walkarounds on the operations floor.
- Support continuous improvement initiatives related to operational compliance.
- Provide additional quality support as required.
Requirements
- Third-level degree in a science, quality, or engineering discipline.
- Minimum of 3 years’ experience in a quality or operations role within a regulated GMP environment.
- Experience in biologics manufacturing and/or aseptic processing is highly desirable.
- Strong understanding of GMP and regulatory compliance standards.
- Excellent communication and documentation skills.
- Ability to work independently with attention to detail and problem-solving skills.
- Comfortable supporting daily operational quality needs and decision-making within quality systems.
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