QC Lab Senior Specialist: Quality Systems SME

Socket.dev; Grand Rapids (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits starting day 1

401(k) immediate vesting

Paid volunteer time

PTO 104 hours/year + WTO

Job summary

GRAM seeks a QC Senior Specialist to support quality systems in the analytical lab. You’ll own CAPA, INTCAPA, AI, NCR, TCR, OOS, and the lab CAPEX program, while training staff and managing LIMS.

You’ll collaborate with QC leadership, Laboratory System Administrator, Analytical Technical Services, QA, and Validation to meet deadlines. The ideal candidate holds a chemistry degree with extensive regulated-lab experience and is proficient in Word, Excel, and Outlook.

Qualifications

• Bachelor’s degree in Chemistry or related discipline and 10+ years regulated lab experience.
• Master’s degree in Chemistry or related discipline and 6+ years regulated lab experience.
• Proficient computer skills in Word, Excel, and Outlook.

Responsibilities

• Process ownership for CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS with on-time deliverables.
• Facilitate laboratory training program including administration of approved trainers and scheduling.
• Serve as QC 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 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 software method design, 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.

Skills

Excellent written and verbal komunik—?

Proficient MS Word, Excel, Outlook

Education

Bachelor’s degree in Chemistry or related discipline

Master’s degree in Chemistry or related discipline

Tools

LIMS

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

GRAM seeks a QC Senior Specialist to support quality systems in the analytical lab. You’ll own CAPA, INTCAPA, AI, NCR, TCR, OOS, and the lab CAPEX program, while training staff and managing LIMS.

You’ll collaborate with QC leadership, Laboratory System Administrator, Analytical Technical Services, QA, and Validation to meet deadlines. The ideal candidate holds a chemistry degree with extensive regulated-lab experience and is proficient in Word, Excel, and Outlook.