Quality Assurance Specialist

NOT OPEN FOR C2C CONTRACTSWe are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.Due to a constant growth, PQE is looking for a Quality Assurance Consultant based in Raleigh, North Carolina. This is a contract role that is onsite for 6 months with a high possibility of extension.ResponsibilitiesConduct minor, major, and critical deviation investigations in their respective areas as necessary and will document such investigations appropriately.Lead root cause analysis investigations with team to members to identify problems and deviations during the project, determine product impact, and assign appropriate CAPAs with responsibilities and due dates within the team.Perform trending analysis'' to identify and report adverse trends and deviations that may require further plete investigations within the specified time-frames.Develop CAPAs to prevent deviations during the project and stay within compliance of FDA regulations.Establish an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective for long-term success.Report performance metrics to project leader on a periodic basis.RequirementsBachelor''s degree from an accredited college/university.At least 3-5 years of experience in pharmaceutical industry, with biologics and/or biotech products preferred.Appropriate written and verbal communication skills in English and in any other relevant language(s).Knowledge and experience with aseptic processing in pharma/biotech manufacturing.Expert level understanding of deviation resolution for manufacturing processes and CAPA management.Previous experience with remediation plans for the FDA.Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, and supplier management.Location: Raleigh, North CarolinaOur collaborators are engaged, developed, challenged and well-rewarded for performance.We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Created: 2025-11-15