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12 days old

CAPA Quality Specialist

Kelly Services
West Hills, CA 91307
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 **CAPA Quality** **Specialist** at a prestigious Fortune 500 company working in **West Hills** **.**





**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:** **CAPA Quality** **Specialist**





**Pay Rate: $28 per hour depending on experience**



***Position is 100% on site**



**Position Summary** :



This position is responsible for the effective processing, monitoring and reporting of the NCR and CAPA programs including support of trending reports for upper management in accordance with company policy and procedures. Ensure compliance to FDA and ISO regulations with respect to CAPA. This position is expected to work independently. Must demonstrate consistent problem solving skills and be able to work on corrective action teams. The level of responsibility for this position is assigned based on the employees OTJ experience within the position description, as well as demonstrated performance. The department manager will outline specific duties during employee reviews.





**Key Responsibilities** :



This position is responsible for monitoring/addressing/tracking quality issues that arise from Non-Conformance (NCR) or from Internal/External quality system audits. This position is also responsible for assisting the QA Supervisor and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities. Additional support of routine QA department standard operating procedures is also expected when necessary.





**Duties and Responsibilities** :



1. Perform computer operations for data entry and provide tracing/trending reports.



2. Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory).



3. Initiates RCA process and notifies QC technicians.



4. Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance.



5. Responsible for the assignment of CAPA reports (corrective/preventive action requests) to NCRs.



6. Ensure all nonconforming product(s) are identified and removed from use.



7. Ensure completion and accuracy of all associated quality records related to non-conformance and CAPA reports.



8. Participate in product related team meetings and/or performance reviews, as needed.



9. Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).



Essential Functions:



To ensure that timely corrective and preventive actions are implemented to prevent and minimize product non-conformances. This position has the authorization to impose quality control limits on any area/process within the company to prevent/establish control of a non conformance.



Contacts and Relations:



This position requires a high degree of interaction with product managers and staff.





**Accountability** :



This position must maintain the confidentiality of all technical data and business information. Individual must be able to give timely professional responses as needed. Maintain professional working relationship with staff and departments.





Education/Training Experience:



Must have a Bachelors Degree in the Biological Sciences or equivalent work experience. Requires a minimum of two (2) years job related experience in a regulated manufacturing environment. Background in IVD products is preferred. ASQ/RAB affiliation preferred.





**Knowledge of** :



1. Detailed knowledge of ISO and GMP regulations which govern an IVD product manufacturing.



2. Knowledge of statistical process controls and GMP CAPA requirements.



3. Tracking and trending tools and reporting techniques.





Microsoft Office Skills:



Able to create presentations, work with spreadsheets, prepare reports



and write procedures utilizing MS Word, Excel and PowerPoint software applications





Ability to:



Provide accurate QS tracking and trending reports. Good procedural writing skills a plus. Exercise independent discretion and judgment in execution of duties. Plan and organize oneself in a consistent manner. Be a self-starter with the ability to positively motivate others in a cooperative fashion. Establish and maintain effective working relationships with other staff members. Effectively communicate both orally and in writing to management, customers and regulatory personnel. Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.







**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 & 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. 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: 2021-01-08 Expires: 2021-02-08

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CAPA Quality Specialist

Kelly Services
West Hills, CA 91307

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