Quality Assurance Tech II: Batch Records & Compliance

Paladin Labs Inc.; St. Louis (MO); On-site; USD 50,000 - 70,000; Full time

Job summary

Paladin Labs Inc. is seeking a Quality Assurance Technician II in St. Louis, MO. The role involves reviewing documentation, ensuring compliance with cGMP regulations, and participating in inspections.

Applicants should have at least a HS Diploma, with a preference for higher education, and relevant experience in a cGMP environment. Proficiency in MS Word and Excel, along with strong communication skills, is essential.

Qualifications

• Minimum of 1–3 years of document review experience in a cGMP environment preferred.
• Ability to read and understand complex batch records.
• Excellent verbal and written communication skills.

Responsibilities

• Execute batch record review and document deficiencies.
• Identify exceptions and report exceptions to production.
• Resolve documentation discrepancies and issues with manufacturing operations personnel.

Skills

Document review experience in a cGMP environment

Knowledge of FDA and cGMP regulations

Proficiency in MS Word and Excel

Effective communication skills

Ability to focus on batch records

Education

HS Diploma

Associates or Bachelor's degree (preferred)

Tools

LIMS

BPCS

TrackWise

Job description

Paladin Labs Inc. is seeking a Quality Assurance Technician II in St. Louis, MO. The role involves reviewing documentation, ensuring compliance with cGMP regulations, and participating in inspections.

Applicants should have at least a HS Diploma, with a preference for higher education, and relevant experience in a cGMP environment. Proficiency in MS Word and Excel, along with strong communication skills, is essential.