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17 days old

Document Control Specialist (Santa Cruz, CA)

Kelly Services
Santa Cruz, CA 95063
Document Control Associate II



Quality Santa Cruz, California



Description



The Document Control Associate II ensures consistency, accuracy and regulatory compliance of product and documentation changes executed through the documentation processes. This position coordinates activities related to the approval and availability of Revision controlled documents, including but not limited to: SOPs, WIs, Finished Product Specifications, Raw Material & Packaging Specification, and Master Manufacturing Records. Additionally, the Document Control Associate II contributes to a variety of ongoing efforts related to relevant process streamlining and improvement.





**Duties and Responsibilities**








+ Review and verify new or changed documents/specifications and processes to ensure compliance prior to final approval.

+ Collaborate cross-functionally (e.g. Account Managers, R&D, Supply Chain, QC, Regulatory) to gather information and provide feedback on issues related to all product documentation.

+ Perform document audits of all new or changed controlled documents.

+ Generate customer change notification letters and track to completion.




+ Ensure continuous certification with ISO, FSSC, FDA, CFIA and other regulations as directed.




+ Understand and follow document Good Manufacturing Practices (GMPs) requirements with a focus on Change Control.

+ Contribute to ongoing process improvements with focus on document accuracy, efficiency and regulatory risk mitigation.

+ Support all departments with corrective actions, audit findings and follow-up.




+ Participate in various teams, including internal audit, sensory, GMP or others as required.




+ Provide regular reports as directed.

+ Update/Create product specific documents, such as Manufacturing batch records, Raw Material Specifications, Finished Product Specifications, Label Graphics, Packaging Specifications

+ Communicate with cross-functional teammates within R D, Product Management, Laboratory in order to complete document updates/creation

+ Work with customers to obtain accurate information to update/create documents

+ Review teammates work to create/update documents

+ Be able to pick up new computer programs in Inventory Management, Product Labeling, Pallet pattern development, and Pallet Placards





**Required Qualifications**








+ High School Diploma or equivalent.

+ 2 years professional Quality or change control experience.

+ Proficiency in Microsoft Office including Excel, Word and Outlook.

+ Strong organizational, follow-up, collaboration, accuracy, analysis, communication, writing and analytical skills.





**Preferred Qualifications**








+ Degree in business, science, engineering or related field.

+ Prior manufacturing, GMP, consumer packaged goods, pharmaceutical and/or nutraceutical industry experience.

+ Bilingual in English/Spanish.





**Physical Requirements**







The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.






**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: 2020-09-04 Expires: 2020-10-05

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Document Control Specialist (Santa Cruz, CA)

Kelly Services
Santa Cruz, CA 95063

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