QC Senior Specialist

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

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About The Position

The QC Senior Specialist supports quality systems as they relate to operations in the quality control analytical lab. Support and ownership of laboratory quality management systems (CAPA, INTCAPA, AI, NCR, TCR, OOS), laboratory training program, equipment qualification/maintenance, LIMS management, and laboratory CAPEX program. This position works closely with QC Laboratory Leadership, Laboratory System Administrator, Analytical Technical Services, Quality Assurance, Validation, and Computer System Validation departments. Position may be specialized by laboratory manager based on need.

Requirements

• Bachelor’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and a minimum of 10 years regulated lab experience.
• Master’s degree in Chemistry and/or other related discipline (e.g. Biochemistry, Biotechnology) and a minimum of 6 years regulated lab experience.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Nice To Haves

• Excellent written and verbal skills; Ability to communicate effectively with management and staff by exhibiting excellent interpersonal skills.

Responsibilities

• Process ownership for laboratory CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS. Includes establishment of deliverables and successful completion of deliverables on time.
• Facilitate laboratory training program including administration of approved trainers and scheduling.
• Serve as the Quality Control subject matter expert (SME) for LIMS, including master data management, change assessment, and project support.
• Author/Review/Approve laboratory quality system deliverables, working cross-functionally to secure approvals in a timely fashion in order to meet deadlines.
• Act as Quality Control lead on laboratory project teams with the ability to make independent decisions regarding internal project deliverables.
• Serve as technical SME for critical topics for the QC department, including but not limited to software method design, laboratory instrument troubleshooting, and mentorship/training of laboratory personnel.
• Resolve technical issues and problems with end users and vendors.
• Develop a strong professional relationship with vendors, co-workers, and clients.
• Process ownership for lifecycle management of laboratory equipment and systems.

Benefits

• Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost!
• Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well.
• Generous off-shift premiums!
• 16 hours of paid volunteer time per calendar year!
• Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year.
• Employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior