Quality Assurance Compliance Associate (Day Shift)

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 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 companys 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 ones 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 ones 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:

• Bachelors 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 centurys experience in providing science-driven solutions to optimize the health wellbeing and productivity of the worlds animals.

Bimedas 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.

Bimedas 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

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.

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1
Yearly Salary Salary: 50 - 57