We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1200 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 constant growth, PQE is looking for Quality Assurance Specialist in Kankakee, IL. The role will be onsite for a 6 month contract with a possibility of extension.
Conduct minor, major, and critical deviation investigations in their respective areas as necessary and will document such investigations appropriately.
Lead root because analysis investigations with team 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 trend analysis' to identify and report adverse trends and deviations that may require further action.
Complete investigations within the specified time-frames.
Develop CAPAs to prevent deviations during the project and to 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.
Bachelor'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, supplier management)