QC Analyst II

Job#: 3017589

Job Description:

Title: QC Analyst II

Client: Biotechnology company

Contract/Perm & duration
: 12-month contract (possibility of extension/conversion)

Location
:
Toronto, Onsite Monday
- Friday

Pay Rate: $30- $35/hr (T4)

Responsibilities:

· Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in their production.

· Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials.

· Liaise with CROs for sample submissions and external testing results reporting.

· Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.

· Write, review and drive approval of SOPs related to quality control testing including test methods, and equipment operation and maintenance procedures.

· Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.

· Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.

· Support QA and QC functions for cleanroom operations, including review and tracking of Environmental Monitoring data and cleanroom maintenance practices.

· Other duties as required.

Minimum Requirements:

· BSc or MSc in Life Sciences, Cell Biology, Genetics, Biotechnology, Biochemistry or related field. Docusign Envelope

· Preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.

· Experience in one or more of the following techniques is required:
Flow cytometry, PCR, Pluripotent Stem cell culture, Fluorescence microscopy, High throughput imaging, Next generation sequencing, ELISA, HPLC.

· Experience with liquid handling robots highly preferred

· Experience in the following areas is highly desirable: cell therapy, pluripotent stem cells, gene editing, biotech.

· Excellent written and oral communication skills, with keen attention to detail and highly organized.

· Demonstrated flexibility in adjusting to changing priorities and schedules.

· Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.

· Occasional weekend work on an as needed basis may be required.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including Clearly Rated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex uses a virtual recruiter as part of the application process.  for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a Support Linc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.

In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach.

You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.