Manufacturing Quality Specialist
1 week ago
Job Overview
We are seeking a highly skilled Quality Engineer to join our team at Randstad Life Sciences US.
About the Role
This is a 6 month contract / temp to perm position, working 100% onsite from Monday - Friday, 3rd shift in North Billerica, MA.
Salary
The salary for this role is estimated to be between $50-55 per hour.
Job Description
As a Quality Engineer, you will provide quality oversight activities for the aseptic fill/finish manufacturing suite and quality assurance technical expertise to ensure compliance with company guidelines and CGMP regulations.
Key Responsibilities
- Conduct investigations and make recommendations for targeted data and information collection as required for quality events.
- Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.
- Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
- Review and approve protocols, validation documents, investigations and procedures.
- Approve change controls and represent Quality in Change Control Board meetings as needed.
- Provide Quality on the floor presence in support of manufacturing operations.
- Represent QA in a range of internal team meetings, processes and initiatives.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Actively promote safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the company values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
Requirements
- Bachelor's degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
- Ability to travel up to 10% domestically.
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