Job Title: QA Assurance Compliance Associate
Location: Cambridge, ON
Position Type: Full-time Regular
Shift: Day Shift, Monday - Friday, 6:30am- 3:00pm
Vacancy Status: This role will be vacant
AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants
Job Summary
Reporting 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.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
FOSTERING COLLABORATION/TEAMWORK – is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
EFFECTIVE COMMUNICATION - is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.
EXECUTION/ACCOUNTABILITY – a willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
THOROUGHNESS/DETAIL ORIENTED – ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
Other Requirements Essential:
- 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.
Compensation & Benefits:
- 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.
About Bimeda
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 global innovation program sees eight state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
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.
More info at www.bimedacareers.com
Equal Opportunity & Accessibility
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.
