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9 days old

Quality Assurance Manager- San Diego, CA

Kelly Services
San Diego, CA 92108
**Quality Assurance Manager** - San Diego, CA


**Summary:**


The Quality Assurance Manager provides leadership and is responsible for establishing and maintaining the quality management systems and processes that meet company and regulatory requirement for cGMP systems. Liaison with senior management to ensure that all Quality Assurance departmental systems and practices are implemented, maintained and followed as per established written procedures.


**Responsibilities.**


+ Promotes quality achievement and performance improvement throughout the organization.

+ Sets QA compliance objectives in alignment with business objectives and ensure that targets are achieved. Leads in development of the company's QMS for evolving needs, compliance to

+ Manage the batch record review process and disposition of manufactured finished goods.

+ Defines, reviews and implement quality system procedures and policies.

+ Develops proposals for system and process development or modifications.

+ Review and approval of events, deviations, CAPA, investigations, change control, non-conformances, etc., to all documents and investigates the results of product and/or process non-conformance.

+ Maintains supplier audit program and ensure timely audits and effective closure of quality issues of supplier and contract organizations providing critical raw materials or services.

+ Leads regulatory agency inspections and customer Quality Audits.

+ Participate in the review of quality agreements and supply agreements from a quality perspective.

+ Support the internal transition of paper to electronic files and transfer of legacy documents associated with products.

+ Effectively manage the company's document management system including oversight of off-site storage of active and archived materials.

+ Reviews the production schedule on a routine basis to maintain knowledge of manufacturing schedules / deadlines / due dates.

+ Generates labels for manufactured products and maintain label control to comply with regulatory requirements. Provide line clearance and technical assistance on all production and quality systems documents/processes as required.

+ Collaborates with different Departments to work on special/other projects as required/assigned by management.

+ Generates and publishes APR reports as required / applicable.

+ Receives other assignments as directed by Manager.


**Requirements/Qualifications** **:**


+ Bachelor's degree or 10+ years related experience and/or training in Quality Assurance preferred, or equivalent combination of education and experience.

+ Knowledge of safety requirements and legal standards

+ Working knowledge of quality system requirements

+ Experience with MS Word, Excel, Project Management and Analytics software.

+ Leadership and project management

+ Proficient in computer skills including report writing, data analysis using Microsoft Excel, and Microsoft Word.

+ Experience using a licensed Quality Management System software strongly preferred, with the ability to learn a new software if needed

+ Experience working in an ISO or GMP regulated environment strongly preferred

+ Knowledge of quality system and regulatory requirements pertaining to the production and sale of FDA regulated products.

+ Strong verbal and written communication skills required


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-15 Expires: 2021-10-16

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Quality Assurance Manager- San Diego, CA

Kelly Services
San Diego, CA 92108

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