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21 days old

Senior QA Specialist

Kelly Services
Durham, NC 27722
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a growing, award-winning biopharmaceutical contract development and manufacturing organization providing fully integrated, drug development and biopharmaceutical services to pharmaceutical and biotechnology companies globally.


**Job Title:** **Sr. QA Specialist**


**Overview:**


Built upon a foundation of world-class analytical capabilities, our client delivers efficient process development, clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Immediately seeking a self-motivated Sr. QA Specialist to support all QA activities related to Facility Engineering and Validation with strong knowledge of qualify principles and equipment qualifications in a pharmaceutical or GMP environment within a cohesive and supportive team in this fast-growing, team based, collaborative environment. This is a newly created position due to company growth!


**Responsibilities may include (but are not limited to) the following:**


+ Involved in the equipment qualification of the whole facility determining if a system has a direct impact on GMP review and provide guidance.

+ Review validation plans, (IQOQPQ).

+ Set, execute QA review and approval of documentation to result in timely oversight of equipment, computer systems, utilities, and facilities to support start-up of a new commercial manufacturing facility and subsequent routine operations.

+ This individual provides quality oversight of facility upgrades and expansions and is responsible for managing the change control system.

+ Qualify systems (IOQs) and perform IOQ documentation.


**Education/Experience Requirements/Competencies** **:**


+ Legally authorized to work in the job posting Country.

+ B.S. degree and 7-10 years of quality with validation experience/knowledge.

+ QA experience in commercial operations is preferred

+ Working knowledge of qualification process, technical reviews, Equipment qualifications, CMMS, deviation, change controls.

+ Knowledgeable with quality principles in a GMP environment is required.


**Generous Compensation and Benefits Package Including Relocation Assistance**


**EOE, including Disability/Vets**


**\#TJP2021_SPEC**


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-24 Expires: 2021-10-25

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Senior QA Specialist

Kelly Services
Durham, NC 27722

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