Quality Assurance Tech III

  • Anywhere

Company :
Mallinckrodt Pharmaceutcals

Location :
St. Louis, Missouri

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Job Title Quality Assurance Tech III Requisition JR Quality Assurance Tech III (Open) Location St. Louis, MO (Pharma) – USA032 Additional Locations St. Louis, MO Job Description SUMMARY OF POSITION: The Quality Assurance Technician III 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, special product inspections, and line clearances as necessary. In addition, they may be responsible for product release, certificate of analysis generation, and completing system transactions for inventory status changes. This role ensures QA compliance and that cGMP principles are adhered to at all times. 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 – Perform official batch record searches for product release of intermediates and finished product lots – Generate release packets for finished product release – Utilize BPCS, LIMS, and JDE to facilitate release functions – Manage status changes and inventory adjustments of production materials in BPCS and JDE – Generate and update Certificates of Analysis documents as needed MINIMUM REQUIREMENTS: Education: – HS Diploma is required; Associates or Bachelors degree is preferred. Experience: – Minimum of 3-5 years of document review experience in a cGMP environment required. Proven knowledge of FDA and cGMP regulations. Proficiency in MS Word and Excel. LIMS, BPCS, and TrackWise experience required. Knowledge/Skills/Qualifications: – Ability to communicate at a high level with both 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 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. Must be able to pass a fit test for respirator use. 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.