Senior QC Specialist

Faculty of Medicine & Dentistry - Medical Microbiology & Immunology

Competition No.  -    A112643312D1
Closing Date  -    Will remain open until filled.

The Li Ka Shing Applied Virology (LKSAV) Group is a collaborative research environment designed to translate and commercialize basic research discoveries. There are ~30 staff from varied disciplines (virologists, chemists, immunologists, computational scientists and GMP manufacturers, etc.) working in the Li Ka Shing Applied Virology Group with more than 10 active projects under development for future clinical testing. In addition, the group actively collaborates with about 12 Principal Investigators from the department of Medical Microbiology & Immunology as well as other University of Alberta departments. It also has active collaborations with Principal Investigators at other Canadian & international organizations. 

This position and will be part of one of the LKSAV group's most exciting projects: the development of an HCV vaccine. this project has been funded by a AIHS CRIP grant and partially by a Government of Alberta fund. A team of fifteen people (research technologists and research associates) currently work on this project. This position will report to the Director and will work in collaboration with other project members to set up and maintain the QC laboratory to meet regulatory requirements for lot release testing of pharmaceutical grade materials destined for clinical trials.

Responsibilities:

  • Set up and lead the QC team to support manufacturing of biologics, for instance, a vaccine against Hepatitis C
  • Coordinates and plans detailed laboratory work plans/schedules including outsourcing of analytical tests.
  • Creates and maintains robust laboratory processes and maintains laboratory quality service by enforcing quality and GMP requirements
  • Assess laboratory capacity, strategize, and deliver results on time
  • Develop stress and stability testing programs in compliance with ICH, FDA and European Medicine Agency guidelines
  • Analyzes and resolves laboratory issues, establishes robust CAPA's
  • Develop training curriculum for department 
  • Understands, uses, and executes laboratory electronic systems including records keeping and signatures
  • Foster a positive working environment of partnership, transparency, and teamwork throughout the QC team and the Institute
  • Responsible for coaching, counseling, and disciplining direct reports; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards
  • Other duties as required

Qualifications:

  • In depth knowledge of QC Laboratory working principles, Good Documentation and Laboratory Practices (GDP and GLP)
  • Educational background preferably in Life Sciences (Biology, Biochemistry or other related fields)
  • Thorough knowledge in the use and application of USP, EP and JP Pharmacopeias
  • Thorough Knowledge of biological products and solid dosage forms
  • Five years or more of hands on working experience in a Quality Control Laboratory. Able to set up the GMP QC lab and maintain compliance with various regulatory jurisdictions.
  • Works effectively with diverse departmental groups
  • Skill, knowledge and experience with processes involved in manufacturing, lot release, stability testing, storage and distribution.
  • Skilled and knowledgeable of assay development and validation including but not limited to ELISA, HPLC, gel electrophoresis, spectrophotometry, PCR, DNA and TOC
  • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply
  • Able to make sound, quality decisions independently
  • Ability to draft and edit Standard operation procedures, stability protocols, validation protocols, etc. 
  • Attention to detail is a must
  • Strong organizational skills and sensitive to project timelines
  • Strong oral and written communication skills
  • Experience working in GMP environments, including cleanrooms is an asset

 This Competition has been re-posted Previous Applicants need not apply

As per the Trust / Research Academic Staff Agreement, this is a Term Excluded position and has an end date of March 31, 2021, with an annual salary range of $58,210 to $80,050 plus vacation pay in the amount of 4%.

How to Apply

Apply Online

Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.

The University of Alberta is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Métis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and the University to apply.