Senior QC Specialist — Lab Quality & Compliance Expert

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteerism starting day 1

Paid time off up to 104 hours per year

Wellness time off

Job summary

Grand River Aseptic Manufacturing, Inc. is seeking a QC Senior Specialist to support quality systems in the analytical lab. You will own CAPA, INTCAPA, AI, NCR, TCR, OOS processes, manage training, and serve as QC SME for LIMS and equipment systems.

You will work with QC leadership, QA, validation, and IT to ensure timely, compliant deliverables and continuous improvement within a regulated facility in Michigan.

Qualifications

• Bachelor’s degree in Chemistry and/or related discipline with minimum 10 years regulated lab experience.

Responsibilities

• Process ownership for laboratory CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS with deliverables.
• Facilitate laboratory training program administration of approved trainers and scheduling.
• Serve as QC SME for LIMS including master data management, change assessment, and project support.
• Author/Review/Approve lab quality system deliverables and secure timely approvals.
• Act as QC lead on laboratory project teams and make independent decisions on deliverables.
• Serve as technical SME for topics like software method design, instrument troubleshooting, and personnel mentorship.
• Resolve technical issues with end users and vendors; build vendor relationships.
• Ownership of lifecycle management for laboratory equipment and systems.

Skills

Excellent written and verbal skills

Microsoft Word

Microsoft Excel

Microsoft Outlook

Education

Bachelor’s degree in Chemistry or related discipline

Master’s degree in Chemistry or related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Grand River Aseptic Manufacturing, Inc. is seeking a QC Senior Specialist to support quality systems in the analytical lab. You will own CAPA, INTCAPA, AI, NCR, TCR, OOS processes, manage training, and serve as QC SME for LIMS and equipment systems.

You will work with QC leadership, QA, validation, and IT to ensure timely, compliant deliverables and continuous improvement within a regulated facility in Michigan.