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Quality Assurance Associate

2 months ago


South Plainfield, United States Scientech Laboratories, LLC Full time

The Quality Assurance Associate is responsible for reviewing laboratory processes, data, and reports of chemical testing using established methods for OTC drug, cosmetic, dietary supplement, and Rx drug products in a FDA cGMP environment for various clients.


Drawing upon 40+ years of experience, Scientech Laboratories takes pride in leading the way in the cGMP-compliant analytical laboratory domain. Scientech supports the OTC drug, Cosmetics, Dietary Supplement, Botanicals, and Pharmaceutical industries with quality testing of finished products and raw materials, support for product development, process development, and formulation, and stability chambers for real-time, accelerated, refrigerated, Zone IVa and IVb studies.


Responsibilities

·      Critically review and release data packages and technical reports produced by Laboratory Team to assure compliance with SOPs and FDA cGMP standards

·      Ensure compliance with Company’s policies and QMS requirements

·      Ensure Standard Operating Procedures (SOPs) and all method documentation is up to date and compliant per FDA cGMP/GLP requirements

·      Collaborate with Lab Team and Client Relations to investigate, troubleshoot, and resolve out of specification (OOS) results

·      Assure all documentation (hard copy and digital) is complete, compliant, and of adequate quality to withstand FDA audit

·      Assist QA Team in upgrading and implementing new solutions for QMS, documentation, and change control

·      Independently manages own day-to-day activities to support Lab objectives


Qualifications

·      BS in Life Sciences with 3+ years experience working in an FDA-regulated analytical chemistry laboratory

·      A strong understanding of cGMP/GLP requirements and QA procedures for an analytical laboratory

·      Experienced with reviewing and drafting Lab data packages, reports, and SOPs

·      Solid understanding of a variety of analytical chemistry analyses such as LC, GC, IR, UV, dissolution, viscosity, melting point, and others

·      Experience with the analysis and GMP reporting process of OTC drug, cosmetic, dietary supplement, and/or botanical products

·      Strong technical writing skills

·      Independent, yet a great Team player.

·      Organized and able to plan work efficiently and effectively.

·      Ability to consistently deliver on-time results for clients.