What are the responsibilities and job description for the Quality Assurance Tech III position at Mallinckrodt?
Job Title
Quality Assurance Tech III
Requisition
JR000014685 Quality Assurance Tech III (Open)
Location
Fenton, MO
Additional Locations
Job Description Summary
Job Description
SUMMARY OF POSITION:
The Quality Assurance Technician III performs a variety of review process with the intent to correct record errors and ensure a timely review and approval of product batch records including batch record review, documentation issue resolution, line clearances, return good inspections, and (current Good Manufacturing Practices) cGMP area inspections. In addition they are responsible for product release, certificate of analysis generation, and completing system transactions for all inventory status changes. This role ensures QA compliance within the site and that cGMP principles are adhered to.
ESSENTIAL FUNCTIONS:
Activities below will be performed daily as needed.
- 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
- Execute line clearances.
- Follow all internal and basic cGMP guidelines for pharmaceutical operations
- Perform GMP walk-throughs with production on a routine basis
- Issuance and accountability of GMP records and finished product labeling
- Filing and Archiving of all GMP documentation
- Participate in cross-functional teams to improve review efficiency and support
- Review of process equipment reports and audit trails for data integrity reviews
- Perform official final batch record searches prior to release of product
- Use BPCS to manage the release function.
- Management of raw material and finished product lot statuses in BPCS
- Assist where needed with the Quality Management Systems.
MINIMUM REQUIREMENTS:
Education: HS Diploma is required; Associates or Bachelor’s degree is preferred. A four year degree in a technical field may be considered toward the minimum experience requirement.
Experience: Minimum of 3-5 years of document review experience in a GMP environment is required. Proven knowledge of FDA and cGMP regulations required.
Preferred Skills/Qualifications: Proficiency in MS Word and Excel.
Other Skills:
- Ability to communicate at a high level.
- Ability to read and comprehend complex calculations and formulas.
- Ability to focus and review batch records for an extended period of time.
- Knowledge for GMPs for Finished Dosage.
- 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.
- Good verbal and written communication skills.
- Ability to understand and apply good documentation practices.
COMPETENCIES:
Organizing, Peer Relationships, Functional/Technical Skill, Time Management, Priority Setting
RELATIONSHIP WITH OTHERS:
Reports directly to the Plant Quality Manager. Daily interaction with Manufacturing personnel, Focus Factory Managers, and Quality.
WORKING CONDITIONS:
85% of Office environment which includes sitting for long periods of time and computer use
15% of Manufacturing environment exposure including temperature, noise, chemical or potent compound 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.
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