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16 days old

Product Release Specialist - Quality Assurance, Gardena, CA

Kelly Services
Los Angeles, CA 90006
**Product Release Specialist - Quality Assurance, Gardena, CA**



**Shift:** 1st; Mon Fri (7:00am 3:30pm)



**Position Summary:** The Product Release Specialist I will perform a wide variety of activities to ensure manufacturing and packaging batch records for bulk and finished packaged product for intermediate and final disposition of lots are in compliance with internal procedures in addition to applicable regulatory requirements by conducting batch record review, audits, data analysis, and other documentation reviews.



**Essential Duties and Responsibilities:**




+ 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 SHC Product Release process are in compliance with current Good Manufacturing Practices (cGMP) and internal policies and procedures.

+ Demonstrates attention to detail, and able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities.

+ 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.

+ 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.

+ Communicates in a professional and timely manner with appropriate personnel (internal or CMO) on missing required documentation, error corrections or other required documentation.

+ Ensure all deficiencies have been appropriately corrected/resolved to meet target shipment dates.

+ Track review, corrections, and resolutions for trending and metrics.

+ Support monthly internal production and CMO metric reports for Quality Management tracking, trending and investigational purposes.

+ Work independently and ensure that documents tied to product release are prioritized appropriately.

+ Participate in process improvement initiatives targeting for Right First Time (RFT) on documentation.

+ As needed, participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.

+ Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations.

+ May be required to perform other duties as assigned or as needed.



**Job Requirements:**




+ Bachelor's degree (BS) in a science related field with at least two (2) years of progressive and/or relevant quality assurance experience in a cGMP environment (e.g., pharmaceutical, dietary supplements, OTC, biotechnology or medical device industry); OR Associate's degree (A.S.) in a science related field with three to four (3-4) years of progressive and/or relevant quality assurance experience in a cGMP environment (e.g., pharmaceutical, dietary supplements, OTC, biotechnology or medical device industry); OR High School Diploma or equivalent with at least five (5) years of progressive and/or relevant quality assurance experience in a cGMP environment (e.g., pharmaceutical, dietary supplements, OTC, biotechnology or medical device industry).

+ Prior experience as a QA Tech within a nutraceutical / dietary supplements industry.

+ Experience as a document Reviewer and/or auditor

+ Strong attention to detail

+ Familiar with investigation and CAPA

+ CMO experience preferred

+ Intermediate Excel and Word knowledge

+ Experience with Access a plus but not necessary

+ Ability to apply an understanding of manufacturing processes and testing requirements to documents related to products at the SHC manufacturing and packaging facilities.

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

+ Ability to perform well under schedule requirements with minimal direct supervision.

+ Willingness to visit and view activities 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 Quality, Production, and Scheduling personnel.

+ Ability to negotiate and to lead multi-disciplinary teams in problem-solving.

+ Superior organizational skills; able to manage more than one project at once.

+ Working knowledge of PC technology (i.e., Outlook, Excel, Word, PowerPoint, Internet, etc.) is required.



**Physical Demands:** While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk and hear. The employee is occasionally required to stand; walk; use hands to finger, handle, feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.



**Work Environment:** While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually quiet.



**For Immediate Consideration, Apply Today! Questions?** **Call Grace at 714-971-0721 or Email at grace.piper@kellyscientific.com**






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-04 Expires: 2019-12-05

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Product Release Specialist - Quality Assurance, Gardena, CA

Kelly Services
Los Angeles, CA 90006

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