QA Specialist - Finishing Operations (cGMP Pharma)

Paylocity; Grand Rapids (MI); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Benefits starting day 1

Paid volunteerism 16 hours/yr

13 days PTO per year

Wellness time off

10 paid holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) seeks a QA Specialist I in Finishing Operations to support quality systems related to the manufacturing and testing of parenteral drugs. You will oversee terminal sterilization, visual inspection, labeling and packaging, and review quality records for release of materials and products.

The role requires 1–2 years of related experience, or an equivalent GMP background, and proficiency with Word, Excel, and Outlook.

Qualifications

• GMP/QA knowledge required or equivalent GMP-related experience.
• Familiarity with QA principles in pharma/biopharma manufacturing.
• Proficient in Word, Excel, Outlook for documentation and tracking.

Responsibilities

• Verify terminal sterilization, visual inspection, labeling and packaging operation documentation.
• Review batch records and controlled documents for accuracy.
• Perform clearance/start-up activities for Finishing Operations and W&B Booth operations.
• QA review and approval of stability and finished product testing certificates of analysis.
• QA review and material release for incoming materials.
• Complete routine quality system tasks (Work Orders, Calibration Forms, etc.).
• Operate in compliance with cGMPs and SOPs.
• Participate in deviation investigations (NCRs, LIRs) to support quality investigations.

Skills

GMP knowledge

QA principles

MS Office

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Grand River Aseptic Manufacturing (GRAM) seeks a QA Specialist I in Finishing Operations to support quality systems related to the manufacturing and testing of parenteral drugs. You will oversee terminal sterilization, visual inspection, labeling and packaging, and review quality records for release of materials and products.

The role requires 1–2 years of related experience, or an equivalent GMP background, and proficiency with Word, Excel, and Outlook.