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22 days old

Quality Assurance Specialist

Kelly Services
Souderton, PA 18964
**Quality Assurance Specialist**



Souderton, PA



Direct-Hire, Permanent Opportunity



Full-Time, Day-Shift





Kelly Scientific Resources has an excellent opportunity as a Quality Assurance Specialist. This position is responsible for the maintenance of the company quality management system, batch record reviews, and the accordance of cGMP.





**Responsibilities:**




+ Review and approve product documentation, including Master Batch Records and Executed batch records.

+ Support Product release, including review of validation reports and other supporting documentation to ensure that all information contained within, is correct and accurate and in a timely manner

+ Provide quality assurance support/advice to operational departments in support of new and existing projects and products. This will involve interaction with internal and external customers to achieve required timelines while maintaining product quality and compliance

+ Actively manage the implementation of quality systems such as deviation, complaints and CAPA management, change controls and risk assessments; and ensure that quality systems are continuously improved with the objective of assuring the GMP compliance and quality of pharmaceutical products. Ensure all internal and customer timelines are met.

+ Liaison with clients to ensure quality expectations are met, including attending client meetings

+ Quarantine products to support vendor queries and investigations as applicable

+ Assist in the compilation and review of APRs, SARs, Technical Agreements, and Risk Assessments

+ Support/feed into the quality system metrics to identify trends and facilitate management review.

+ Carry out internal and external audits to ensure GMP compliance and assist in customer and regulator audits, as appropriate

+ Identify, write, approve and implement critical GMP documents within Pharma Services and assist in training as required on new/ revised procedures

+ Additional duties related to the assurance of GMP compliance and quality of manufactured and released pharmaceutical products, may also be assigned.





**Qualifications**




+ Education:

+ High School/GED equivalent **required** .

+ Bachelors degree preferred.

+ Required:

+ 3 years of experience (with HS Diploma) OR 2 Years (with Bachelors Degree)

+ Knowledge of the basic GMP requirements of the pharmaceutical industry.

+ Preferred:

+ Experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility.

+ Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging processes.






**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: 2019-11-15 Expires: 2019-12-16

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Quality Assurance Specialist

Kelly Services
Souderton, PA 18964

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