Lilly QA Associate - FDE (Contract) in Guelph, Ontario


Title QA Associate - FDE (Contract)

City Guelph

State / Province Ontario

Country Canada

Company Overview Elanco Animal Health, a division of Eli Lilly Canada Inc., is engaged in the discovery, development, manufacturing, and marketing of innovative animal health products. Elanco is a world leader in developing products and services that enhance animal health, wellness and performance. Elanco products contribute to the production of an affordable and abundant supply of food. Our half-century of innovative products, services and global partnerships help to fulfill our vision of food and companionship enriching life.

Responsibilities We are currently seeking a Quality Associate to join our team in Guelph.

Reporting to the Quality Leader, the Quality Associate is responsible for completion of Quality processes and providing expert advice and assistance to the division.

Quality is the part of GMP concerned with sampling, specifications, and testing and with the organization, documentation, and release procedures. The Quality Unit ensures that the necessary and relevant tests are actually carried out and that raw materials and packaging materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. Quality is not confined to laboratory operations but is incorporated into all activities and decisions concerning the quality of the product.

Key Responsibilities include:

  • Ensure the disposition/release of high quality products, in accordance with approved internal and corporate standard operating procedures, specifications, Health Canada Regulations and product specific regulatory commitments. Includes evaluation of transportation, storage, and distribution conditions. Products include:

  • Finished Products

  • Packaging

  • Labeling

  • Returned Goods

  • Preparation and evaluation of quality documentation including:

  • Deviations

  • Change Control

  • Product Quality Complaints

  • Annual Product Reviews

  • Coordination and assessment of product specific stability data in accordance with the approved stability schedule, stability protocol, specifications and Regulatory Commitments.

  • Development of standard operating procedures in accordance with Health Canada Regulations and Corporate Standards.

  • Performing of external and internal audits

  • Completion of scheduled activities as listed on the site Quality Plan.

  • Designing and delivering GMP training programs.

Basic Qualifications Education, Training and Experience:

  • Bachelor or advanced degree in chemistry, biochemistry, microbiology, pharmacy or closely related discipline.

  • Thorough knowledge of the Food and Drugs Act, Food and Drug Regulations, cGMP Regulation

  • Preferably, one to two years experience in a pharmaceutical QA/QC environment.

  • Recent graduate with pharmaceutical regulatory affairs and quality operations education.

Skills :

  • Works independently in a self-managed environment.

  • Able to interpret data and information from a variety of sources drawing appropriate conclusions based on a thorough understanding of good scientific practice, Good Manufacturing Practice requirements and company policies and procedures.

  • Investigates and/or assists others in the investigation of issues with the potential to impact product quality and/or compliance to GMP requirements.

  • Suggests and implements solutions balancing good science, product quality impact, GMP compliance, cost and business needs.

  • Accepts responsibility for self and team.

  • Ability to work under pressure and make rapid and accurate decisions.

  • Challenges existing methods and processes in an effort to find areas for improvement.

  • Drives the implementation of new methods and processes.

  • Competent in using personal computer and MS office package software.

  • Organizational, leadership and project management skills

  • Strong interpersonal skills.

  • Facilitating and coaching skills.

  • Able to balance a variety of tasks with the appropriate priority.

  • Well-developed written and verbal communication skills.

  • Aptitude for critical thinking and problem solving.

Removal Date 15-Sep-2017