QA Associate: GMP & Batch Record Specialist

Actalent; Michigan; On-site; USD 27,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO)

Job summary

Actalent is seeking a QA Associate in Clinton, IN to review data supporting product and packaging quality. You will ensure compliance with cGMPs, write and revise SOPs, and interact with QC and Material Control to support batch releases.

The role focuses on batch records, COAs, and QA documentation, with a 7:30 am–4:00 pm, Monday–Friday schedule in a fully onsite manufacturing environment.

Qualifications

• BS/AS degree or 12+ months QA/GMP experience.
• Strong documentation and math skills.
• Attention to detail in a regulated environment.

Responsibilities

• Support Quality systems and production area.
• Review, print, and maintain manufacturing records.
• Coordinate with QC lab on test results for batch release.
• Approve raw materials and COAs, manage COA requests.
• Prepare batch records and labels; print AQIS/docs as needed.
• Own documents in Veeva Vault for QA approvals.

Skills

Quality Assurance

Batch Record

GMP

QA Testing

Quality Documentation

Titration

pH Testing

Analytical Skills

Biology

Chemistry

COA

Laboratory Experience

SOP Review

Education

B.S/A.S Degree in related field or QA/GMP experience

Job description

Actalent is seeking a QA Associate in Clinton, IN to review data supporting product and packaging quality. You will ensure compliance with cGMPs, write and revise SOPs, and interact with QC and Material Control to support batch releases.

The role focuses on batch records, COAs, and QA documentation, with a 7:30 am–4:00 pm, Monday–Friday schedule in a fully onsite manufacturing environment.