Job Details

Senior Quality Assurance Specialist

Title
Senior Quality Assurance Specialist
Accepting BioReady
Yes
Length
Full Time
Employer

Evonik Canada Inc.

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

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: 

Please email your resume to minnie.khera@evonik.com when applying for this position.