POSITION : Quality Assurance Specialist

REPORTS TO : Quality Manager

SALARY : Compensation $55,000-$70,000 plus bonus.

TERMS OF EMPLOYMENT: Permanent - Full Time

LOCATION : Charlottetown, PEI

Island Abbey Nutritionals™ is an established natural health and specialty food dietary supplement product producer based out of Prince Edward Island, Canada. Proven industry leaders, we offer cutting-edge, globally patented technologies for production of gummy products for dietary supplement, natural health, and specialty food industries.

The Quality Assurance (QA) Specialist is responsible for supporting and maintaining quality systems and compliance across all manufacturing operations. The role emphasizes training coordination, cleaning and equipment validation support, stability studies quality support, documentation control and overall Quality Assurance system support. The ideal candidate will have experience in the pharmaceutical/biological/medical device, food or dietary supplement, or industry and be comfortable working in a fast-paced, regulated environment. We are seeking a detail-oriented and proactive QA Coordinator to join our quality team.

Key Responsibilities

• Support the design, execution, and review of cleaning validation studies for manufacturing equipment and facilities.
• Ensure cleaning processes meet microbiological and allergen control requirements
• Work closely with Sanitation, QA, and Production teams to investigate cleaning quality events or failures and implement corrective actions
• Provide Quality Support in developing Stability Summary Reports
• Develop, deliver (as required), and track GMP and job-specific training programs for all relevant personnel
• Maintain employee training files and ensure compliance with training requirements
• Draft SOPs, Protocols, Technical Reports, and memos in support of Quality activities
• Conduct Quality reviews of production documentation associated with quality issues, including deviations, change controls, discrepancies, and reworks
• Support initiation and execution of Out of Specification (OOS) investigations as required by internal procedures and reporting OOS results and investigations to the Quality manager

immediately as they occur

• Ensure quality oversight and governance of root cause investigations and associated risk assessment processes
• Support management of vendor and customer complaint investigations, resolution, and tracking
• Assist in performing QA review of Batch Production Records (BPRs) to support finished goods release
• Perform supplier audits and review of supplier documentation as directed by the Quality Manager
• Participate in and support internal and external audits. Prepare documentation packages for internal and external audits (e.g., FDA, third-party certifications)
• Conduct internal inspections and walkthroughs to ensure compliance with SOPs and GMPs
• Monitor and ensure compliance with Good Manufacturing Practices (GMP), Food Safety regulations, and company quality policies
• Assist in coordinating with 3rd party lab for managing raw and finished products, and environmental monitoring activities
• Performs other duties as assigned

Qualifications

• 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
• 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
• Strong attention to detail and organizational skills
• Excellent technical writing and verbal communication skills is mandatory
• 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
• Must be well organized and demonstrate effective time management skills
• High attention to detail

Other Must have proof of eligibility to work in Canada

PHYSICAL ASPECTS OF POSITION (INCLUDES BUT IS NOT LIMITED TO): This Position Requires The Ability To

• Stand, or walk for an extended period on a hard surface
• Life up to 25 lbs
• Work in a variety of temperatures
• Working with personal protective equipment
• Noise