Quality Assurance Compliance Associate (Day Shift) 24 Months Contract Role
Bimeda View all jobs
- Cambridge, ON
- $50,000-57,000 per year
- Contract
- Full-time
Location: Cambridge, ON
Position Type: Full-time, 24 Months Contract RoleShift: Day Shift, Monday - Friday, 6:30am- 3:00pm
Vacancy Status: This role will be vacant in May 2026
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicantsJob SummaryReporting to the QA Compliance Associate, this role will work within an established culture of quality assurance and continuous improvement in all GMP areas. This role will be directly involved in all areas of quality assurance, including change controls, Annual Product Reviews (APRs), review of technical documents, deviation resolution, managing CAPAs, and ensuring GMP standards are met. In addition, the role will participate in handling customer complaints and inquiries of the products. This role will include coaching and training operators and supervisors on proper documentation practices and on cGMP requirements.Key Role Specific Requirements
- Conducting annual product reviews by reviewing all production documentation and summarizing key issues and preparing final reports on the quality of the product manufactured.
- Assessing potential impact of incidents and processing deviations on the quality and suitability of the product for sale. Includes conducting batch record review and determining batch status, e.g., release, reject or product hold for further clarification or investigation.
- Providing oversight and quality assurance approval to various systems (CAPA, deviation, change requests) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented, and consistently managed.
- Investigating both individually and as a team member, product complaints, deviations, and out of specification results to determine product impact, root cause and corrective/preventative actions.
- Monitoring quality assurance systems and advising/presenting to executive team on system performance; publishing metrics/reports regarding performance against set goals.
- Lead change control initiatives and facilitate documentation updates utilizing Microsoft Word and ZenQMS software.
- Performing internal quality audits that are compliant with corporate policies, practices, and procedures.
- Collaborating with client-facing quality representatives to ensure full customer satisfaction with the company’s products and services.
- Providing support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.
- Promoting and advocating quality achievement and performance improvement across the organization.
- Ensuring ongoing compliance with local, national, and international standards and legislation.
- Participating in HPRA, FDA & client audits and ensuring corrective actions are completed as required.
- Creating and maintaining QA control documentation.
- Bachelor’s degree in a related Science along with specific Quality Assurance education or training
- Minimum 2 years of direct work experience with pharmaceutical Quality Assurance systems, regulations, guidelines, and associated standards
- Direct knowledge of pharmaceutical Quality Assurance methodologies
- Training and knowledge of cGMP regulations
- Extremely detail-oriented and analytical thinker with strong problem-solving ability
- Able to develop, review, and maintain metrics and quality audits
- Able to interface directly with cross-functional teams
- Proficiency in use of computer applications and programs such as Word, Excel, and Power Point
- High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative.
- Competitive salary.
- 13 paid holidays.
- Competitive vacation policy effective upon hire.
- 5 paid personal care days.
- Employee Assistance Program.
- Expected Salary Range: $50k -$57k /Year.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs. We are committed to an inclusive and accessible recruitment process. We are an equal-opportunity employer and assess candidates based on skills and experience. Recruitment records are retained in accordance with Ontario law.