QA Associate III

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.