QA Technician II: Batch Records & GMP Compliance

Paladin Labs Inc.; St. Louis, Northern (MO, KY); Hybrid; USD 52,000 - 76,000; Full time

Job summary

Par Health is seeking a Quality Assurance Technician II to perform batch record review and resolve documentation issues in manufacturing. You will participate in inspections of returned goods and ensure cGMP compliance, working with production and quality teams in a predominantly office environment with some manufacturing exposure.

The role requires 1–3 years of document review experience in a cGMP setting, proficiency in MS Word/Excel, and knowledge of FDA regulations.

Qualifications

• HS Diploma required; further degree preferred.
• 1–3 years of document review in a cGMP environment preferred.
• Proficient with MS Word and Excel.
• Knowledge of FDA and cGMP regulations preferred.
• Experience with LIMS, BPCS and TrackWise preferred.

Responsibilities

• Execute batch record review and document deficiencies in a computerized system.
• Identify and report exceptions to production.
• Resolve documentation discrepancies with manufacturing operations for material release.
• Perform batch record accountability and box reconciliation.
• Execute line clearances and assist in inspection of returned goods.
• Follow cGMP guidelines for pharmaceutical operations.
• Conduct GMP walkthroughs with production.
• Participate in cross-functional teams to improve review efficiency.
• Maintain 100% safety training completion and Compliance Wire training.

Skills

Attention to detail

Communication skills

Reading comprehension

Education

HS Diploma

Associates or Bachelor's degree preferred

Tools

MS Word

MS Excel

LIMS

BPCS

TrackWise

Job description

Par Health is seeking a Quality Assurance Technician II to perform batch record review and resolve documentation issues in manufacturing. You will participate in inspections of returned goods and ensure cGMP compliance, working with production and quality teams in a predominantly office environment with some manufacturing exposure.

The role requires 1–3 years of document review experience in a cGMP setting, proficiency in MS Word/Excel, and knowledge of FDA regulations.