QA Specialist

Factors Group of Nutritional Companies•Coquitlam, BC

13h•Onsite

About The Position

The Quality Assurance (QA) Specialist’s main responsibility is to review and release bulk and finished goods, ensuring they meet approved specifications and all regulations. This is a Permanent Full-Time position working 40 hours per week, Monday to Friday from 8:00 am to 4:30 pm, and is an Onsite role.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Food Science, or related field (required).
Experience in QA, cGMP, Food Safety and Regulatory Compliance in the pharmaceutical or dietary supplements industry (3-5 years).
Experience with regulatory compliance of products regulated under FDA 21CFR111, USP, NHPD and TGA or other relevant compliance experience with manufacturing of pharmaceutical, dietary supplements or excipients.
Experience working hands-on in a dietary supplement or similar manufacturing environment, including pre-operational inspections, internal audits, and compliance monitoring and trending.
Computer proficiency with MS Office (Word/ Excel), MRP program and data entry.

Nice To Haves

Experience with QMS, LIMS, CAPA systems (an asset).

Responsibilities

Review and release bulk, packaging raw materials and bought-out batch records using LIMS and MRP program, assign expiration dates and shelf-life extensions, make potency adjustments, complete APQRs (Annual Product Quality Review) in compliance with various standards.
Initiate and investigate Deviations, Corrective Actions, Change Control and Non-Conformances.
Contribute to monitoring and trending of process performance to ignite continuous improvement initiatives.
Review and release new and revised bulk and raw materials specifications and formulas in LIMS.
Initiate, review, and approve re-work plans and certificate of analysis for bulks and finished products.
Provide support during internal and external quality audits.
Complete APQR reports.