QA Specialist, GMP — On-the-Floor Quality Oversight

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance and disability benefits

401(k) with immediate vesting

Paid volunteer time

PTO

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing, Inc. (GRAM) seeks a Quality Assurance Specialist to support quality systems for aseptic drug product manufacturing and testing. You will oversee deviation and CAPA processes, batch record reviews, SOP revisions, and quality document reviews within a cGMP environment.

The role requires a Life Sciences degree (or equivalent GMP experience) and 2–5 years in a related field, with strong MS Word/Excel/Outlook skills. On-site work in Grand Rapids, MI, is expected.

Qualifications

• Bachelor’s degree in Life Sciences or related field, with 2–5 years related GMP/pharma experience.
• Ability to complete tasks with accuracy and efficiency.
• Proficient computer skills in MS Word, Excel, and Outlook.

Responsibilities

• Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance.
• Establish and maintain good technique with regards to working in classified areas (including gowning qualification).
• Review and approve executed batch records and other associated controlled documents.
• Perform QA review in-process, environmental monitoring test results, and material release for incoming materials.
• Participate in cross functional teams to support quality investigations.
• Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.

Skills

Attention to detail

MS Word/Excel/Outlook

Clear communication

Education

Bachelor's degree in Life Sciences or related field

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Grand River Aseptic Manufacturing, Inc. (GRAM) seeks a Quality Assurance Specialist to support quality systems for aseptic drug product manufacturing and testing. You will oversee deviation and CAPA processes, batch record reviews, SOP revisions, and quality document reviews within a cGMP environment.

The role requires a Life Sciences degree (or equivalent GMP experience) and 2–5 years in a related field, with strong MS Word/Excel/Outlook skills. On-site work in Grand Rapids, MI, is expected.