Job Details

GMP Quality Control Specialist

Title
GMP Quality Control Specialist
Length
Full Time
Employer

STEMCELL Technologies

Salary
Yearly
not disclosed
Location
Vancouver, BC
British Columbia
Date Posted
07/02/2018 - 08:00
Closing Date
07/03/2018 - 08:00
Accepting BioReady
Yes
Job Description
Summary: 

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore.  Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training.  We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree.  STEMCELL is proud to be the largest Biotechnology employer in Canada.

This role will report to Manager, Quality Control, Raw Materials and Stability, and will also be expected to generate and update raw material specifications and applicable documentation. 

QC Specialist, Raw Materials is responsible for the inspection and sampling of incoming raw materials used in the manufacturing of GMP products.

Education & Qualifications: 
  • BSc. in one of life sciences with 3-5 years industry experience
  • Experience in raw material specification review and documentation
  • Experience working in a higher compliance environment is an asset
  • Proven ability to effectively collaborate, multitask and work in a fast paced environment
  • Must be well-organized, capable of careful record-keeping and pay close attention-to-detail
  • Excellent written and oral communication skills
Duties & Responsibilities: 
  • Accurately follow established procedures and perform tasks in accordance with cGMP requirements
  • Perform inspection and sampling of incoming raw materials required for manufacturing in GMP facility
  • Complete inspection and sampling per schedule and within TAT
  • Maintain the sampling room according to internal procedures
  • Distribute raw materials to testing teams (internal or external laboratories)
  • Participate in the creation and revision of raw material specification
  • Perform inspection and release of incoming raw materials required for manufacturing in ISO 13485 facility
  • Participate in non-conformance investigations, supplier change notification assessments, corrective and preventative actions and change control with specific emphasis on utilization of product and compliance knowledge.
  • Participate in projects for continuous improvement initiatives within QC department and corporately
  • Assist in preparation and review of quality records including standard operation procedures (SOPs)
Other Information: 

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities. If you are interested in this challenging and rewarding position, please apply online at https://jobs.stemcell.com/