Posted on: May 5, 2021
Title: QA Specialist Location: East Windsor, NJ Schedule: M-F,
8-5 (8hr day) some OT needed on occasion during week and possible
on weekend if needed. Type: Temporary Start date: ASAP
- Responsible for reviewing specifications, procedures,
protocols, and records for GMP compliance.
- Responsibilities also include GMP audits of the plant,
coordinate and track closeouts of deviations, change control
requests, consumer complaints, and out-of-specification
- Perform review of batch production and control records for OTC
products and initiate investigation for any unexplained discrepancy
found during review.
- Prepare Certificate of Manufacturing and Compliance and release
OTC products for shipment.
- File and maintain batch production and control records for OTC
- Review raw material, packaging material, in-process material
and finished product specifications for GMP compliance -
Reconciliation of OTC Batch Records.
- Prepare master production records for all OTC products if
- Coordinate and track completion of action items generated due
to deviations and change control requests
- Provide assistance writing OOS, Consumer complaint
investigation, metrics reports. Present data through meetings and
as written documents. Propose appropriate CAPAs to avoid
- Administers CAPA system focusing on CAPA approval, closure and
- Conduct Internal Quality Audits. Report observations and other
potential concerns to the auditees and management, both through
verbal presentation and written audit reports.
- Conduct Annual Product Review of OTC products.
- Provide GMP Training to other departments as needed
- Researches and prepares data needed for monthly quality metrics
- Assist in any project/task assigned by the Manager.
- BS Bachelor's degree preferably with a Engineering or Science
- Must have minimum of Two years knowledge of pharmaceutical GMP
- Must have 2-4 years experience quality assurance experience in
a regulated industry (cosmetic or pharma or related) including:
Batch record review/reconciliation, CAPA.OOS
- Must have good understanding of 21CFR (Part210-211), ICH
- Expert in Excel and PowerPoint presentation Good presentation
- Must have batch record review experience Joule, a System One
division is a leader in specialized workforce solutions and
integrated services. With more than 6,000 employees and roughly 50
offices throughout the U.S. we provide scientific, clinical,
engineering, energy, IT, legal and administrative staffing
services. For more than 40 years, we have delivered workforce
solutions and integrated services to clients nationally.
Keywords: Joule, Trenton , QA Specialist, Other , Hightstown, New Jersey
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