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Quality Assurance Technician II
Ref No.: 18-21741
Location: Greenville, Illinois
Job Title: Quality Assurance Technician II
Location: Greenville, IL 62246
Duration: 6 Months

Summary of position:
  • The Quality Assurance Technician II performs a variety of review process 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, (current Good Manufacturing Practices) cGMP area inspections and product inspections
  • This role ensures QA compliance and that cGMP principles are adhered to.

Essential functions:
  • 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

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 and BPCS experience preferred.

Knowledge/Skills/Qualifications:
  • 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 GMPs 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

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, chemical or potent compound exposure.
  • Must be able to pass a fit test for respirator use, 16 panel drug screen, and the Client's background check.