Bimeda Hiring for Quality Assurance Associate at Cambridge, ON Full Time

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals. Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids. Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
About the role:
Reporting to the QA Supervisor, the QA Associate will work within an established culture of Quality Assurance and continuous improvement in all GMP areas. The QA Associate will be directly involved in all areas of quality assurance, including change control, Annual Product Reviews (APRs), product release, review of technical documents, deviation resolution and ensuring GMP standards are met. In addition, the QA Associate will participate in handling customer complaints and inquiries of the products. The role includes coaching/training operators and supervisors on proper documentation practices and on cGMP requirements.
What you’ll do:

• 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 QA 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 OOS results to determine product impact, root cause and corrective/preventative actions.
• Monitoring QA 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 QA audits that are compliant with corporate policies, practices, and procedures.
• Collaborating with client-facing QA 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 Health Canada , FDA & customer audits and ensuring corrective actions are completed as required.
• Creating and maintaining QA control documentation.

What you bring to the role:

• University degree in a related Science along with specific Quality Assurance education or training
• Minimum 2 years of direct work experience with pharmaceutical QA systems, regulations, guidelines, and associated standards
• Direct knowledge of pharmaceutical QA 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, ability to organize and prioritize, team player, willing to take initiative

What We Offer:

• Competitive Salary
• Paid Holidays
• Competitive Vacation Policy
• Paid Sick Days
• Medical, Dental, Vision Insurance
• Pension plan
• Employee Assistance Program

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.

Location: Beaverdale Rd,Cambridge,ON 420 Beaverdale Road,Cambridge,N3C 2W4 Country CA ON ON, Cambridge, ON

Job Type: Full-time

Work Location: Multiple Locations