Job Details

Senior Quality Assurance Specialist

Senior Quality Assurance Specialist
Accepting BioReady
Full Time

Evonik Canada Inc.

not disclosed
British Columbia
Date Posted
02/10/2018 - 10:30
Closing Date
02/11/2018 - 10:30
Job Description

Senior Quality Assurance Specialist

Evonik Industries, its Burnaby, B.C. site, specializes in parenteral formulation development and manufacturing process design and implementation at small, intermediate, and large/commercial scales. This enables manufacturing of complex lipid-based formulations of therapeutic agents for preclinical and clinical testing in its state-of-the-art R&D and manufacturing facilities and transfer of drug product manufacturing to commercial facilities. Core manufacturing technologies include liposome extrusion, micro-mixing, tangential flow filtration (TFF) and sterile filtration with availability of small to large-scale equipment.

Education & Qualifications: 
  • BSc in science related field with a minimum of 10 years’ experience in Quality Assurance, Quality Control, and Compliance or Pharmaceutical Formulation environment.
  • In depth knowledge of regulatory requirements i.e. GMP, GLP, etc and experience with GMP documentation review
  • Excellent technical writing and communication skills
  • Self-motivated and able to work independently and as part of a team
  • High attention to detail and well-organized
  • Ability to multi-task in a fast-pace environment with changing priorities
  • Strong interpersonal skills with the ability to influence others across multiple functions
  • Exhibits initiative to recognize and solve problems
Duties & Responsibilities: 
  • Reviewing and approving Analytical Reports and associated Raw Data for in-house and external analytical testing, including release and stability testing of Drug Products and Test Articles
  • Reviewing and approving Analytical method Validations and method transfer including the review of Laboratory Notebooks, HPLC chromatograms, and Validation Reports
  • Releasing Raw Materials and supplies for manufacturing, when required
  • Reviewing completed Batch Records for manufacturing of Drug Products and Test Articles
  • Reviewing DQ/IQ/OQ/PQ of all equipment to ensure compliance with applicable regulatory requirements
  • Assisting in the organization and planning of company-wide cGMP required training
  • Performing other relevant quality assurance, compliance record review tasks as required
Other Information: 

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