Job Information
Mallinckrodt Pharmaceuticals Quality Assurance Tech III in Fenton, Missouri
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 exposureDISCLAIMER:
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.
At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
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