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Quality Assurance Tech II jobs in United States
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Endo · 18 hours ago

Quality Assurance Tech II

positionSt. Louis, MO (Pharma) - USA032
timeFull-time
remoteOnsite
seniorityEntry Level
date1+ years exp
Mallinckrodt Enterprises LLC is a company committed to improving lives through quality healthcare. The Quality Assurance Technician II is responsible for performing review processes to correct record errors in manufacturing documentation, ensuring QA compliance, and adhering to cGMP principles.
Pharmaceuticals
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Comp. & Benefits

Responsibilities

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

Qualification

CGMP knowledgeDocument review experienceFDA regulations knowledgeMS Word proficiencyMS Excel proficiencyLIMS experienceTrackWise experienceOrganizingWritten communicationOral communicationAttention to detailTime management

Required

HS Diploma is required
Minimum of 1-3 years of document review experience in a cGMP environment preferred
Proficiency in MS Word and Excel
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
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
Ability to understand and apply good documentation practices
Organizing
Peer Relationships
Functional/Technical Skill
Time Management
Priority Setting
Attention to Detail

Preferred

Associates or Bachelor's degree is preferred
Proven knowledge of FDA and cGMP regulations preferred
LIMS, BPCS, and TrackWise experience preferred
Knowledge of cGMPs for APIs
Excellent verbal and written communication skills
Ability to build relationships with partners

Company

Endo

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Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
dateFounded in 1997
location
Malvern, , US
people-size1001-5000 employees

Funding

Current Stage
Late Stage

Leadership Team

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Blaise Coleman
President and Chief Executive Officer
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Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
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Recent News

PR Newswire
Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with Three New Concentrations
2025-09-23
PR Newswire
Mallinckrodt Names Dr. Marek J. Honczarenko as EVP and Chief Scientific Officer
2025-09-22
PR Newswire
Endo Presents Plantar Fibromatosis and Plantar Fasciitis Data at the American Orthopaedic Foot & Ankle Society Annual Meeting
2025-09-12
Company data provided by crunchbase