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QC Analyst I - Raw Materials
Job Description
The QC Analyst I – Raw Materials is responsible for carrying out and coordinating routine raw material sampling activities to support GMP manufacturing. This includes tracking incoming materials, planning sampling, and reviewing and entering external test results into internal systems and maintaining laboratory spaces.
This role requires routine aseptic gowning and entry into classified cleanroom environments to perform raw material sampling activities in accordance with GMP requirements and contamination control procedures. The incumbent ensures sampling activities are performed accurately, compliantly, and on schedule to support manufacturing timelines.
Responsibilities:
This role requires routine aseptic gowning and entry into classified cleanroom environments to perform raw material sampling activities in accordance with GMP requirements and contamination control procedures. The incumbent ensures sampling activities are performed accurately, compliantly, and on schedule to support manufacturing timelines.
Responsibilities:
- Perform routine GMP sample collection, labeling, and chain-of-custody documentation to support timely raw material disposition and release.
- Coordinate with Warehouse Operations to facilitate sample logistics, including material movement and shipment of samples to designated Contract Testing Laboratories (CTLs).
- Perform routine cleaning of equipment within GMP cleanroom areas, as well as general laboratory upkeep activities, to maintain inspection-readiness in all QC owned areas.
- Maintain required qualifications for entry into GMP cleanroom areas, including aseptic gowning and GMP material movement in accordance with site procedures.
- Serve as a qualified trainer for the Raw Material Sampling Area following a period of sustained positive performance in aseptic gowning practices.
- Ensure accurate and timely review, reconciliation, and upload of external laboratory results into internal quality systems with assistance from management.
- Support deviation, investigation, and CAPA activities related to sampling operations as needed, with management guidance and oversight.
- Support Warehouse operations with material movement activities into GMP cleanroom areas as a secondary responsibility, in accordance with GMP and aseptic handling procedures.
- GMP, pharmaceutical, biotech, or regulated laboratory experience preferred.
- Hands-on experience or familiarity with raw material sampling and GMP documentation practices preferred.
- Experience coordinating with QMS Systems (Veeva) and Oracle is a plus
- Working knowledge of data integrity principles, chain-of-custody expectations, and sample lifecycle management preferred.
- Strong organizational, communication, and time-management skills working independently after receiving instruction, with the ability to manage multiple priorities in a fast-paced environment following established procedures.
- Ability to work cross-functionally with QC, Warehouse, Manufacturing, Quality Assurance, and external partners.
- Experience coordinating with QMS Systems (Veeva) and Oracle is a plus
- Ability to stand for extended periods with periodic stooping, bending, or kneeling.
- Ability to lift, push, and pull up to 50 lbs.
- Capability to climb ladders and stairs of varying heights.
- Work in a laboratory and warehouse-adjacent environment requiring personal protective equipment (PPE) for head, face, hands, feet, and body.
- Work in temperature-controlled environments, including cold rooms.
- Must remove make-up, jewelry, and contact lenses when working in clean room-associated spaces.
- Must successfully complete a vision exam assessing near and mid-range clarity, depth perception, and color differentiation with or without correction.
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Explore exciting job opportunities in and around Bedford, Massachusetts! Located in Middlesex County, just a short drive from Boston, this charming town offers a perfect blend of suburban tranquility and urban convenience. With close proximity to historic sites like the Bedford Flag and the Minute Man National Historical Park, as well as a thriving arts scene showcased at the Higgins Art Gallery, job seekers can enjoy a rich cultural experience while advancing their careers. Indulge in delicious New England cuisine, catch a show at the nearby Merrimack Repertory Theatre, or cheer on the beloved Boston Red Sox at Fenway Park. Embrace the picturesque beauty of nature at nearby Bedford Center Park or take a stroll by the Concord River. Don't miss the chance to grow both personally and professionally in this vibrant and dynamic region!