Sr. Associate, Quality Assurance

4 weeks ago


Branchburg, United States Piper Companies Full time

Piper Companies is looking for a Sr. Associate, QA who is responsible for performing QA activities in support of the quality system for a Therapeutic Manufacturer in Branchburg, NJ.

This position will be onsite in Branchburg, NJ 3x per week with occasional visits to Philadelphia, PA office.

Responsibilities for the Sr. Associate, QA include:

·Initial review of SOPs, Work Instructions, Qualification, Validation and other reports and controlled documents

·Evaluate and investigate deviation reports

·Assist with implementation and validation of electronic QMS

·Review and approve executed batch records

Qualifications for the Sr. Associate, QA include:

·Bachelor’s of Science Degree in a scientific/technical field (Chemistry, Biology, Microbiology, Engineering, etc.)

·5+ years of GMP related experience, preferably in the early phase biologics or cell therapy

·Experience reviewing/revising GMP related documents including SOPs, Batch Records, Validation/Qualification reports, etc.

·Full understanding of regulatory requirements and QMS

·Experience with electronic system implementation and validation is a plus

Compensation for the Sr. Associate, QA include:

·Hourly Rate – Commensurate with experience

·Full benefits package:

oMedical, Dental, & Vision (Starts the 1st of the month after start date)

o2 weeks PTO, 6 Paid Holidays, 401k

oSubsidized Benefits through Piper Companies

#LI-KP1 #LI-ONSITE #pando



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