Job Title

Quality Assurance Tech II

Requisition

JR000015003 Quality Assurance Tech II (Open)

Location

St. Louis, MO

Additional Locations

Job Description Summary

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.

Job Description

ESSENTIAL FUNCTIONS:

Execute batch record review and document deficiencies in a computerized systemIdentify exceptions and report exceptions to productionResolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material releasePerform batch record accountability and Iron Mountain box reconciliationExecute line clearances and assist in inspection of returned goodsFollow all internal and basic cGMP guidelines for pharmaceutical operationsPerform GMP walkthroughs with production on a routine basisParticipate in cross-functional teams to improve review efficiency and supportAdhere to all safety rules and maintain 100% completion of all safety required trainingMaintain 100% on time Compliance Wire training

MINIMUM REQUIREMENTS:

Education:

HS Diploma is required; Associates or Bachelor’s degree is preferred. 

Experience:

Minimum of 1-3 years of document review experience in a cGMP environment preferred.  Proven knowledge of FDA and cGMP regulations preferred.  Proficiency in MS Word and Excel.  LIMS, BPCS, and TrackWise experience preferred.

Knowledge/Skills/Qualifications:

Ability to communicate at a high level of written and oral skillsAbility to read and comprehend complex calculations and formulasAbility to focus and review batch records for an extended period of timeKnowledge of cGMPs for APIsAbility to quickly identify, communicate and/or resolve issuesAbility to read and understand complex batch recordsAbility to keep batch records organized and easily retrievable at all timesExcellent verbal and written communication skillsAbility to understand and apply good documentation practicesAbility to build relationships with partners

COMPETENCIES:

Organizing, Peer Relationships, Functional/Technical Skill, Time Management, Priority Setting, Attention to detail

RELATIONSHIP WITH OTHERS:

Works with Manufacturing and Quality personnel on a daily basis

WORKING CONDITIONS:

85 % Office environment which includes sitting for long periods of time and computer use.15 % Manufacturing environment exposure including temperature, noise, or chemical exposure.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.