Quality Assurance Specialist - Jobs in Oakville, ON

Job Description

ABOUT USHealthology International Inc. is a leader in the natural health product industry. Our focus is on developing high quality health products that have a profound impact on peoples health.1. OVERALL RESPONSIBILITIESThe Quality Assurance Specialist is responsible for ensuring that all GMP and company quality standards are met with respect to Natural Health Product Good Manufacturing Practices and associated NHP Regulations.2. DUTIES AND RESPONSIBILITIES- Approve or reject all processes, specifications, controls, tests and examinations, and deviations from or modifications to them, that may affect the identity, purity, quality, strength, and composition of all Healthology or Salus products.- Determine whether all finished product lots conform to specifications prior to release for sale and approve or reject based on these criteria.- Ensure product specifications are compliant and current with all manufacturing partners.- Assess all product returns to determine disposition.- Review customer complaints and non-conformities and determine if investigation is required, conduct the investigation, determine if corrective/preventative action are required, perform follow up on corrective action and maintain all associated documentation.- Responsible for reviewing adverse events and determining if the event is serious and must be reported to Health Canada.- Ensure a process is developed and implemented to coordinate and approve changes. Ensure that the description of the change, reason for the change and the approvals are documented. Quality also reviews the document at the end of the process and gives the final approval for the change.- Label creation/revision – When new products are created, quality works with key people in Marketing and product development to create a label where applicable.- Review and approve all processes for calibrating instruments and ensure that the facility instrument calibration program is maintained.- Maintain product stability program and ensure all standards are met.- Maintain product sample retention program with manufacturing partners.- Develop and maintain Standard Operation Procedures (SOPs) associated with the GMP compliance of the facility and processes.- Maintain all quality records in accordance with Health Canada requirements.- Perform audits are required- Verify that contract laboratories are qualified to undertake testing on behalf of the company and its brands.- Maintain pharmacovigilance program- Assist with product recall management.- Maintain company GMP training programs and records- Liaise with Health Canada with respect to any compliance or enforcement activities and work to resolve any such issues.- Other duties not included here may be required.3. KEY COMPETENCIES- Self-motivated with ability to work with minimal supervision- Excellent interpersonal skills with the ability to work in a team environment- Ability to handle strict deadlines and work under pressure.- Demonstrates strong relationship-building with multiple internal and external stakeholders- Ability to critically review scientific literature with a focus on product safety and efficacy substantiation- Excellent knowledge and understanding of GMPs, Food Safety and Health Canada Regulations for Natural Health Products and Food- Effective analytical problem solving and organizational skills- Detail-oriented and excellent written and oral communication skills.4. KNOWLEDGE AND SKILL REQUIREMENTS- University education or equivalent in pharmacology, chemistry, biology, or related scientific discipline- 3-5 years of industry experience with quality assurance for natural health products or pharmaceutical products- Strong computer skills and experience- Strong Excel and software skills- Strong written and presentation skillsJob Types: Full-time, PermanentSalary: $60,000.00-$80,000.00 per yearJob Types: Full-time, PermanentSalary: $60,000.00-$80,000.00 per yearBenefits:

• Dental care
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Store discount
• Vision care

Schedule:

• 8 hour shift

COVID-19 considerations:We are a small office and well spaced. We provide PPE as needed.Experience:

• quality assurance: 3 years (required)

Application deadline: 2022-10-31Expected start date: 2022-12-01Quick Apply

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