Quality Assurance Tech II

Endo•Saint Louis, MO

13h

About The Position

The Quality Assurance Technician II performs a variety of review processes with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is also responsible for return good inspections, cGMP area inspections and product inspections. This role ensures QA compliance and that cGMP principles are adhered to.

Requirements

HS Diploma is required; Associates or Bachelor’s degree is preferred.
Minimum of 1-3 years of document review experience in a cGMP environment preferred.
Proficiency in MS Word and Excel.
Proven knowledge of FDA and cGMP regulations preferred.
LIMS, BPCS, and TrackWise experience preferred.

Nice To Haves

Ability to communicate at a high level of written and oral skills
Ability to read and comprehend complex calculations and formulas
Ability to focus and review batch records for an extended period of time
Knowledge of cGMPs for APIs
Ability to quickly identify, communicate and/or resolve issues
Ability to read and understand complex batch records
Ability to keep batch records organized and easily retrievable at all times
Excellent verbal and written communication skills
Ability to understand and apply good documentation practices
Ability to build relationships with partners

Responsibilities

Execute batch record review and document deficiencies in a computerized system
Identify exceptions and report exceptions to production
Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
Perform batch record accountability and Iron Mountain box reconciliation
Execute line clearances and assist in inspection of returned goods
Follow all internal and basic cGMP guidelines for pharmaceutical operations
Perform GMP walkthroughs with production on a routine basis
Participate in cross-functional teams to improve review efficiency and support
Adhere to all safety rules and maintain 100% completion of all safety required training
Maintain 100% on time Compliance Wire training