10 days old

Quality Systems Manager (Irvine, CA)

Kelly Services
Irvine, CA 92604
Quality System Manager, Irvine, CA

+ Responsible for management of personnel in Quality Systems including QA Documentation Control, QA Change Control, Quality Systems and QA GMP Training.

+ Leads and directs all activities relating to change control, documentation control, GMP training, annual product reviews, annual reporting, implementation and maintenance of Quality Assurance Systems to assure cGMP compliance.

+ Accountable for independent decisions affecting product quality in terms of quality systems, costs, and people.

+ Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc.

+ Processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. Also, archival of records.

+ Collection, compilation, analysis, and review of all data and information supporting the validation status of a products including at least manufacturing, packaging, testing, sourcing, deviations, stability, and changes Annual Product Review Management of formal process for issuing the batch manufacturing and/or packaging record with assigned batch numbers to operations for execution

+ Review/approval of all documentation associated with the validation of the procedures used to clean the equipment train for a products manufacturing and packaging process and cleaning verifications, Process validations and Validation master plans.

+ Review and approval of all continual improvement projects affecting Quality at a site.

+ Review/approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment. This includes any Installation Qualification IQ , Operational Qualification OQ , and Performance Qualification PQ documents.

+ Tracking, trending, and reporting of Quality Metrics for site, regional, and global review.

+ Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.

+ Review of regulatory and quality compliance requirements and Corporate Standards, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability.

+ Development and monitoring of corrective action plans where needed.

+ Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification.


+ Prefers a BS degree in a scientific discipline or advanced education in Science or Life Science field.

+ 10 - 15 years experience in pharmaceutical manufacturing and/or testing.

+ Electronic Document Management Systems EDMS , Management of more than 5 direct reports, Root Cause Analysis, Quality System Implementation, Continuous improvement.

+ Demonstrates a thorough knowledge of Quality Systems, Documentation practices and general processes throughout Teva, including a good working knowledge of TPM system applications Thorough knowledge of cGMPs, FDA, EMEA and other regulatory guidelines Ability to evaluate new technology for implementation e.g. new TrackWise or LIMS

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-11-20 Expires: 2020-12-21

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Quality Systems Manager (Irvine, CA)

Kelly Services
Irvine, CA 92604

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