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Quality Manager

Company: United Exchange Corporation
Location: Cypress
Posted on: January 16, 2022

Job Description:

United Exchange Corporation is an established and fast-growing manufacturer/distributor of health and beauty care consumer products. UEC is seeking a Quality Manager/Senior to direct all aspects of Supplier Quality Management Program including supplier qualification audits/assessments, product quality assessments, develop/approve Quality Agreements and maintenance of the Approved Supplier List.
Duties and Responsibilities include, but not limited to:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Develop, evaluate and revise processes/procedures to ensure compliance to GMP/GLP/GCP regulations and guidelines
Manage various QMS processes including Document and Records Control, Nonconforming Records, Internal Audits, Supplier Management, Quality Certificates, Training, Customer Complaints, Analysis of Data, Design & Development and CAPA.
Supports all aspects of Supplier Quality Management Program including supplier qualification audits/assessments, product quality assessments, ongoing supplier evaluation/audits/assessments, develop/approve Quality Agreements and maintenance of the Approved Supplier List.
Provides quality leadership and guidance for equipment qualification, facility commissioning and qualification, manufacturing process validations and software validation
Ensure that contracted suppliers comply with GMP/GLP/GCP regulatory requirements and relevant SOPs
Provides QA review and approval of production batch records and testing results, specification changes, product nonconformance's, deviations and protocols/reports (e.g., validations, qualifications, capability, stability).
Execute gap analysis and/or risk assessments (HA, FMEA) to ensure evaluation of critical systems, processes and equipment are in compliance with all regulatory requirements (e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO).
Leads, manages or participates in quality projects and teams for continuous improvement of internal quality system infrastructure and external manufacturing processes.
Represent the Quality Unit during internal/external audits, FDA and other regulatory inspections
Alerts line management of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units. Exercises independent judgment.
Ensure completeness, accuracy and compliance of all documentation including CAPA management.
Perform and manage training of internal personnel to permit execution of required tasks and ensure compliance to regulatory requirements/policies/SOPs
Develop and prepare quality data/metrics for Management Review
Maintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.

Required Education and Experience:
Bachelor of Science in Engineering, Chemistry, Management, Quality or related field
5+ years Quality Assurance management experience; 2+ years in pharma industry
Extensive Knowledge with 21 CFR 210, 211, and 820; food regulations a plus
Experience working with Contract Manufacturing Organizations (CMO)
Experience in Pharmaceutical manufacturing and validations

This job is in house - no remote work available.

Keywords: United Exchange Corporation, Cypress , Quality Manager, Executive , Cypress, California

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