QA Associate III

North Cove, NC

Contracted

Experienced

JOIN OUR TEAM!
PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

Onsite; 6+ months (depending on investigation results)
Nightshift ; Weekend work (As needed)

Requirements:

Microbial Investigation SME
Working knowledge of TrackWise to manage investigation and CAPA documentation
Determines scope, product impact, root cause, corrective and/or preventive actions of microbial excursions including surfaces, viable air, non-viable air, water, bioburden and endotoxin testing results
Identify potential root causes for excursions and immediate mitigation actions
Assemble cross-functional teams, conduct interviews, observe operations to complete investigations, and lead process improvement CAPA projects to timely and effective closure
Present and defend investigations during regulatory inspections, as required
Must have great Technical Writing skills.
Bachelor or Master’s degree in science in Microbiology or related field with 2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry but with minimum 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality.

PharmaLex is a Equal Employment Opportunity Employer.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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QA Associate III

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