Quality Assurance Coordinator

We are seeking a proactive Quality Assurance Coordinator to join our team. In this role you will support all Quality Systems to ensure quality manufacturing of products as defined by current Good Manufacturing Practices (GMP). You will assist other departments with quality and GMP issues ensuring compliance with all relevant regulatory requirements. You will also be accountable for the timely release of bulk softgel capsule products to cGMP standards.

Responsibilities:

• Act as a qualified person in the release of finished products as defined by relevant GMP guidelines.
• Follow and maintain GMPs and GLPs for the facility.
• Utilize ERP LIMS and QMS systems for daily functions.
• Work in a team environment to ensure all Quality job functions are covered.
• Support QC Samplers/Technicians and R&D onsite with LIMS tasks.
• Assist other departments with qualityrelated issues.
• Audit batch records and approve the release of materials and products in the ERP system.
• Review and disposition material and product Certificates of Analysis (CofAs) in the LIMS system.
• Handle and coordinate Out of Specification investigations in LIMS.
• Manage the Material retest/expiry program and rejection process.
• Prepare revise or approve master formulas batch records and material/product specifications.
• Lead specification update projects including supplier alignment.
• Coordinate Environmental monitoring and trending results.
• Review and trend Purified Water System testing results.
• Perform production batch adjustments and review lot continuations.
• Prepare rework/reclaim masters and conduct formal AQLs and carton AQLs.
• Conduct internal audits complete reports and track corrective actions.
• Perform rotational facility inspections and assist with external audits.
• Prepare and review documentation for facility customer thirdparty certification and government audits.
• Maintain accurate QMS systems/databases including deviation investigations complaints change control and CAPA.
• Investigate trend and complete reports for deviations complaints and OOS.
• Create and implement CAPA plans and conduct CAPA Effectiveness checks.
• Initiate continuous improvement training notices and operational communications.
• Review and approve change control deliverables.
• Back up Quality Associate duties including SOP system training files document filing & archives quality metrics and temperature/humidity monitoring.
• Conduct new hire GMP orientation training and write or revise SOPs and controlled forms.
• Review production logs QC logs and facility records.
• Prepare or review RMQ and VQ packages.
• Prepare Annual Product Reviews (APR) and Trend reports.
• Review validation protocols data and reports.
• Prepare technical documents and study protocols.
• Order lab supplies.
• Work in compliance with Health & Safety Policies/SOPs.

Qualifications:

• Minimum Bachelors Degree in a sciencerelated field.
• Minimum 2 years of practical Quality department experience in a pharmaceutical nutritional food or health products manufacturing environment.
• Comprehensive knowledge of manufacturing operations and cGMP.
• Experience in softgel manufacturing is an asset.
• Knowledge of pharmaceutical food and natural health product regulations.
• Excellent communication and problemsolving skills.
• Proficient with computers and quality systems software.
• Teamoriented with a high work ethic.
• Selfstarter and critical thinker.
• Ability to work with minimal supervision including shift work and overtime as required.

We prioritize personal ownership and accountability in our work. We value respect actively listening to and engaging with diverse perspectives. We strive for excellence constantly challenging the status quo and pursuing innovative ideas. Agility is key as we embrace change and swiftly incorporate feedback to improve our performance. Join our team and contribute to the efficient and compliant production of highquality products!

About Trevor Frances: Trevor Frances is a specialized talent solutions firm dedicated to connecting skilled professionals with opportunities across various industries. We offer permanent positions with leading companies.