19 days old

Quality Assurance Specialist - Gardena, CA

Kelly Services
Gardena, CA 90247
**Quality Assurance Specialist Gardena, CA**

The QA Specialist is ultimately responsible for the quality, accuracy and completeness of documentation prior to release of product and archiving of GMP documentation related to production, while overseeing the work of the of Product Release Specialists who review controlled documents for accuracy and completeness

**Essential Duties and Responsibilities:**

+ Establishes daily work assignments for the QA Product Release group in alignment with manufacturing targets and commercial demand.

+ Ensures review of batch records and production records in addition to activities associated with product release are prioritized appropriately.

+ Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to applicable procedures.

+ The supervisor is highly competent and knowledgeable in all the activities of Product Release (internal and external) and is responsible to ensure all personnel in area is trained and competent to applicable procedures.

+ Develop working relationship with CMO to align quality initiatives (e.g., CAPA, CIP, etc.) and maintain collaborative relationship with suppliers in support of Quality Systems for Documentation, Change Control, Deviations, Investigations and Complaints for bulk and finished products produced externally.

+ Audit internal and Contract Manufacturing Organizations (CMO) production batch records and other production documentation for accuracy and completeness and identifying deficiencies and suggested resolutions for correction.

+ Support monthly internal production and CMO metric reports for Quality Management tracking, trending and investigational purposes. Define and analyze trends in quality performance with supply chain (e.g. materials, manufacturing, and final product), driving the troubleshooting and implementation of corrective actions where necessary.

+ Acts as the point of contact for GDP/GMP or other quality related issues dealing with product release. Escalates any issues to supervisor/manager for resolution, as deemed necessary.

+ Apply knowledge of current Good Documentation Practices (cGDP) through experience with quality reviews of manufacturing and packaging batch records for bulk and finished packaged product for intermediate and final disposition of lots.

+ Ensure that all documents supporting the Product Release process are in compliance with current Good Manufacturing Practices (cGMP) and internal policies and procedures.


+ Bachelors degree or higher in a science related field preferred with a minimum three (3) years of progressive work experience and/or Leadership or, High School Diploma, GED or Associate Degree (A.A.) with a minimum five (5) years of progressive work experience

+ Prior experience managing direct reports in a cGMP/cGDP regulated environment is required.

+ Ability to apply an understanding of manufacturing processes and testing requirements to documents related to products.

+ Able to perform data analysis extracted from databases and paper records.

+ Ability to perform well under schedule requirements with minimal management support.

+ Willingness to investigate discrepancies and lead problem solving teams in a factory and/or laboratory setting in order to understand documentation.

+ Extraordinary attention to detail and ability to maintain consistency.

+ Strong interpersonal communication with team.

**For immediate consideration, apply today! Contact Toni for further inquires at 714 454 8252 OR**

**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: 2020-08-31 Expires: 2020-10-08

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Quality Assurance Specialist - Gardena, CA

Kelly Services
Gardena, CA 90247

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