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1+ months

Quality Associate

Kelly Services
Hayward, CA 94540
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Quality Associate** at a prestigious Fortune 500 company working in **Hayward.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Quality Associate**





**Pay: $33.68 per hour**





**Position Summary**

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.




**Essential Duties and Responsibilities**



The incumbent will perform other duties assigned.



Leads ongoing, daily departmental operations.



May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.



Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.



Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.



Determine the logic, adequacy and effectiveness of processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance.



Inform management and implement approved corrective action plans.



Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.



Provide training and coaching to local employees and others as needed on relevant area(s).



When required, assist other Quality areas in the successful performance of these activities.



Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.



Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills



Support process with timely closure of observations/audit items.



Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead.



Other duties, tasks or projects as assigned.




**Qualifications**



Strong interpersonal skills and great attention to detail are necessary.



Must be a strong team player with good problem solving, and good verbal and written communication skills.



Must have the ability to manage people, encourage teamwork and drive decisions.



Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.




**Education and/or Experience**



BS in business/science or equivalent. 3-5 years exp. in Quality with a medical.





Top Technical skills needed: Audit Preparation Experience, Compliance knowledge and Regulations, Lead Compliance gaps and remediation activities. Preferred / Optional CQA or qualified auditor for doing internal audits.

Will they need to enter clean room? Yes

Hours: Mon-Fri regular






**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










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



Kelly Science 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. 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

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Posted: 2020-05-29 Expires: 2020-07-30

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Quality Associate

Kelly Services
Hayward, CA 94540

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