Overview:
Are you ready to make a significant impact in the biopharma sector? We have an exciting opportunity for a QA Specialist to join our expanding client heading into 2025. This role offers a 24/7 rotational schedule (7-7 shift pattern) with a competitive shift allowance to reward your dedication and flexibility.
Your Main Focus:
- Provide effective Quality leadership and governance within designated areas.
- Manage quality-related responsibilities, ensuring compliance with all regulatory standards.
- Approve critical quality documents and oversee quality assurance processes.
- Promote a strong culture of safety, ensuring daily operations align with site safety policies.
- Conduct on-floor quality audits, GMP implementation, and systems reviews to maintain operational excellence.
- Own quality assurance for department-manufactured products while mentoring operations teams and QA colleagues to drive compliant, risk-based solutions.
What You Will Do:
- Review and approve GMP documents, including SOPs, raw material specifications, and process flow documents.
- Evaluate and approve change controls, deviations, investigations, analytical results, complaints, and stability studies.
- Assess and approve validation documents for facilities, equipment, utilities, methods, and processes.
- Investigate and dispose of raw materials, intermediates, and packaging components as required.
- Govern batch disposition activities, including batch record approvals and CoA verifications.
- Provide regulatory expertise for relevant processes and documentation.
Experience and Skills You Bring:
- Bachelor's, Master's, or Doctorate in Chemistry, Engineering, or related discipline with at least 1 year of production or relevant experience.
- Exceptional attention to detail and strong problem-solving abilities.
- Proven experience in cross-functional teamwork and decision-making.
- Proficiency in data analysis, critical thinking, and root cause analysis.
- Excellent organizational skills and a commitment to completing tasks effectively.
- A positive, self-motivated attitude with the ability to perform under pressure.
- Flexible and adaptable to meet evolving business demands.
Why Join Us?
- Be part of an innovative and growing biopharma company.
- Competitive salary with an attractive shift allowance for 24/7 rotational shifts (7-7 pattern).
- Gain hands-on experience in a dynamic, collaborative environment.
- Build your career in a role where quality truly makes a difference.
Apply Today and take the next step in your Quality Assurance career!
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
