QC Senior Specialist: Lab Quality & CAPA SME

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

Benefits offered by this job

Benefits starting day 1

Paid volunteerism

PTO/WTO

Paid holidays

Pay depends on experience

Job summary

Grand River Aseptic Manufacturing (GRAM) is seeking a QC Senior Specialist to strengthen our quality control analytical lab. You will own CAPA, INTCAPA, AI, NCR, TCR, and OOS processes, support LIMS, and help maintain training and equipment qualification programs.

The role collaborates with QC Leadership, QA, Validation, and Computer System Validation teams to ensure timely, compliant deliverables in a fast-paced, science-driven environment.

Qualifications

• Bachelor's degree in Chemistry with 10+ years regulated lab experience or Master's degree with 6+ years experience.
• Experience in CAPA, INTCAPA, AI, NCR, TCR, OOS and change control is preferred.
• Strong computer skills with MS Office suite are required.

Responsibilities

• Own and manage laboratory CAPA, INTCAPA, AI, NCR, TCR, Change Control and OOS deliverables.

Skills

CAPA management

Laboratory quality systems

Excellent communication

Project leadership

Training coordination

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry

Tools

LIMS

Microsoft Word

Excel

Outlook

Job description

Grand River Aseptic Manufacturing (GRAM) is seeking a QC Senior Specialist to strengthen our quality control analytical lab. You will own CAPA, INTCAPA, AI, NCR, TCR, and OOS processes, support LIMS, and help maintain training and equipment qualification programs.

The role collaborates with QC Leadership, QA, Validation, and Computer System Validation teams to ensure timely, compliant deliverables in a fast-paced, science-driven environment.