Quality Assurance Specialist
About Us
We provide full-service contract manufacturing, bottling, and packaging solutions for gummy natural health products, supporting clients from concept through launch. Operating within a regulated manufacturing environment, we are committed to quality, compliance, and continuous improvement.
The Opportunity
The Quality Assurance (QA) Specialist is responsible for supporting GMP compliance, product quality, batch release activities, investigations, and Quality System processes across manufacturing operations. The role supports management of Quality Events, risk assessments, complaints, adverse events, CAPAs, OOS investigations, audits, training, and document control to ensure compliance with regulatory, customer, and internal requirements.
What Success Looks Like
- Reliable support for quality process, ensuring compliance with GMP and company standards.
- Timely investigation and resolution of quality issues.
- Accurate training coordination and up-to-date documentation.
- Strong support during audits and effective teamwork across departments.
Responsibilities
Quality Operations & Investigations
- Perform Quality review of completed Batch Production Records (BPRs), laboratory results, deviations, and supporting documentation to verify compliance and support finished product disposition and release.
- Support Quality management of deviations and non-conformances (Quality Events) from initiation through closure, including classification, immediate actions, investigation, root cause analysis, product impact assessment, corrective actions, and documentation of conclusions.
- Facilitate and document quality risk assessments for products, processes, materials, equipment, suppliers, changes, investigations, and other Quality related activities.
- Manage customer and vendor complaints, including intake, assessment, investigation, root cause determination, response preparation, corrective action follow-up, and closure.
- Support the assessment, escalation, investigation, documentation, and reporting of adverse events in accordance with internal procedures and applicable requirements.
- Coordinate corrective and preventive actions (CAPAs), including action plan development, assignment and tracking of actions, verification of completion, effectiveness review, and timely closure.
- Initiate, coordinate, and support Out of Specification (OOS), and other laboratory investigations, and promptly escalate significant results to the Quality Manager.
- Support Quality oversight for change controls, discrepancies, rework, material disposition, and other manufacturing or Quality System activities requiring documented Quality assessment and approval.
- Draft, revise, and review SOPs, protocols, technical reports, investigation reports, risk assessments, memoranda, and other controlled Quality documents.
- Support supplier qualification activities, review supplier documentation, perform supplier audits as directed, and assist with third-party laboratory coordination for raw materials, finished products, and environmental monitoring.
- Monitor and trend Quality System data, including deviations, non-conformances, complaints, CAPAs, OOS results, audit findings, and training compliance, to identify recurring issues, adverse trends, and opportunities for continuous improvement.
Audits & Continuous Improvement
- Participate in internal, supplier, customer, certification, and regulatory audits; prepare supporting documentation; and assist with audit responses and follow-up actions.
- Conduct GMP inspections and facility walkthroughs, identify compliance gaps, communicate observations, and track required corrective actions.
- Performs other duties as assigned.
This job description is not intended to be all-inclusive. Employees may be required to perform other job-related duties as needed to meet business, operational, quality, safety, or regulatory requirements.
Qualifications
Experience & Education
- Bachelor’s degree in Food Science, Chemistry, Biology, Nutrition, or related field.
- 3+ years Quality Assurance experience in dietary supplements, pharmaceutical, biologics, medical device, food, or related regulated manufacturing industry.
Technical Skills
- Knowledge and experience working with GFSI standards (SQF, BRC, FSSC), HACCP, SOP’s, GMP’s would be considered an asset.
- Working knowledge of cleaning validation principles and GMP requirements.
- Microbiology knowledge and sampling will be an asset.
- Experience with cloud-based QMS platforms (e.g., MasterControl, Trackwise, Veeva, SAP, CATSWeb or similar).
- Proficient in the use of Microsoft Office products.
Competencies
- Strong attention to detail and organizational skills.
- Excellent technical writing and verbal communication skills is mandatory.
- Must be well organized and demonstrate effective time management skills.
- High attention to detail.
Working Conditions & Physical Requirements
- Stand or walk for an extended period on a hard surface.
- Lift up to 25 lbs.
- Be present in manufacturing environment which can be noisy, hot, cold and require PPE.
Our Commitment to Inclusive Hiring
We are committed to building an inclusive and accessible workplace. We welcome applications from individuals of all backgrounds and experiences. Accommodations are available throughout the recruitment process upon request.
