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United Exchange Corp: Quality manager/senior

United Exchange Corp

This is a Full-time position in Cypress, CA posted March 22, 2020.

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:Interact with CMOs, Contract Laboratories, Supply Chain (Purchasing), regulatory personnel and with external counterparts at contract organizations to ensure compliance with the company quality policies, and documentation (ex: CAPAs) associated with development, manufacture and distribution of commercial products as per requirements of 21CFR Part 210/211/820.Manage the QA/QC activities for incoming products from contract manufacturers (CMOs).Manage the quality control testing activities at contract labs and oversee laboratory investigations.Prepare QC product specifications, and create/review/approve certificates of analysis.Approve product batch record reviews and evaluation process.Hands on management and support of QA activities including but not limited to batch clearance, quality hold and destruction processes.Conduct investigations (including customer complaint investigations), and root cause analysis.Initiate and implement CAPAs to address findings, issues and non-compliances in the facilities.Author, revise, and train on SOPs, protocols, forms, and work instructions as required.Manage/Direct training of internal personnel to ensure compliance to regulatoryrequirements/SOPs.Assure that Quality complies with cGMP, and other regulatory and industry standards.Manage the Stability testing at CMOs and contract labs, stability protocols and records.Oversee the transfer of methods to and from QC Labs and CMOs as needed.Review analytical and test method protocols and reports.Review a variety of analytical testing of raw materials and finished products.Experience with variety of laboratory equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, Viscometer, Moisture Apparatus, Melting Point apparatus, etc.Understand a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations (USP).Continually evaluate quality systems supporting cGMP operations for potential improvements.Alert line management of significant quality, compliance, supply and safety risks, often requiring the coordination of activities across organizational units.

Exercises independent judgment.Develop and prepare quality data/metrics for Management ReviewMaintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations.Participate during FDA inspections, internal audits and CMO and laboratory audits.Must be detail oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality and compliance.Possess leadership skills with the ability to develop employees and maintain an atmosphere of growth and achievement; a self-starter with minimum oversight required to accomplish goals.Must possess excellent communication and technical writing skills, strong interpersonal skills and the ability to work with others in a positive and collaborative manner; able to communicate with a sense of urgency to internal and external customers.Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master inventory system/regulatory/compliance software.Required Education and Experience:Bachelor’s degree in Chemistry, Biology, or related field.8+ years QA/QC experience; 8+ years in pharma or dietary supplement industry.Experience in auditing CMOs and Laboratories and with FDA Inspections are preferred.Experience working with Contract Manufacturing Organizations (CMOs) are a plus.Experience working in in Pharmaceutical or OTC manufacturing environment.ASQ certifications are a plus.