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15 days old

Quality Assurance Associate

Kelly Services
Durham, NC 27722
Kelly Scientific is currently seeking a **Quality Associate** who will be responsible for Quality oversight at and ensuring compliance with regulatory requirement and company procedures. The Quality Associate is responsible for ensuring that our partners who provide services for the manufacturing, testing, and distribution of our products and manage our clinical studies adhere to the same high standards to protect patient safety and the integrity of our data. This role reports to our Sr Director, Quality.



**This is a temporary 2-3 month contract/consulting opportunity**


**_Responsibilities_**




+ Implement and monitor the cGMP Quality Management System.

+ Provide support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards for the Quality Management System.

+ Author, review and/or approve GMP documentation, including but not limited to Standard Operating Procedures, Work Instructions, Specifications, Batch Records, Audit Records, Protocols, Reports, and Forms using GDP

+ Maintain the electronic Quality Management System (PSC-ACE).

+ Support the vendor management program, including Quality Agreements, auditing program, and CAPA system for audit findings or vendor quality issues

+ Support the Change Management process by authoring and managing change controls.

+ Support Non-conformance/CAPA Management system. Provide initial review ensuring deviations from established procedures are appropriately documented and investigated to determine root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans.

+ Evaluate batch records as part of the release process that meets specifications.

+ Ensure release testing has been performed and appropriate documentation is generated and stored with the batch records.

+ Conduct regular internal audits and self-inspections.

+ Assist and facilitate information in support of regulatory facility audits and inspections as needed.

+ Support the training program as required by Quality Management.



**Minimum Qualifications**



+ Minimum B.S. degree in preferably microbiology, chemistry or biochemistry or 5 years applicable industry experience

+ A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations

+ Should be highly knowledgeable in cGMPs, GLPs, GDPs

+ Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and non-conformances

+ Excellent oral and written communication skills with strong technical writing experience required

+ Experience with internal and supplier audits preferred.

+ Experience with PSC-ACE Quality Management System software is a plus.



Apply today for immediate consideration!






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



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-08-02 Expires: 2019-09-05

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Quality Assurance Associate

Kelly Services
Durham, NC 27722

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