Analyst II, QC Operations

Location: Toronto

Job#: 3034671

Job Description:

Position:
Analyst II, QC Operations

Client:
Innovative Biopharma client

Contract/Perm & duration: 12-month contract (potential for extension)

Location:

Downtown Toronto, 5 days/week onsite

Pay rate: $30-35 /hr

Description of Position:

The Quality Control (QC) Analyst II - QC Operations will provide support for a wide variety of QC Operational requirements for the laboratory activities facilitating testing of cell-based therapeutics destined for human clinical trials. The QC Analyst II will be one of the key contributors in operational excellence, driving all aspects of the QC laboratory operations and compliance through appropriate quality systems.

The candidate will report to the Manager, QC Operations and also work closely with the QC Testing team and Analytical Sciences team to support scheduling, turnaround time on routine testing and method qualification/validation, as well as sample and material management. The QC Analyst II will be instrumental in ensuring compliance within the laboratory through change control, deviation and CAPA, and audit support.

The candidate will also facilitate the management of all QC instrumentation from purchasing to qualification and implementation, preventative maintenance, and data management. Duties include control of the GMP documentation and data generated, aiding in the quality and compliance of the laboratory operations and data integrity for testing in the QC lab to meet applicable U.S., Canadian and global standards.

Responsibilities:

* Execute QC operational activities to support the QC Testing team and Analytical Sciences team to ensure timely release of and compliance for cell therapies.

* Liaise with Logistics to coordinate sample and material inventory requirements, shipment processes, and other external vendor support activities.

* Liaise with Facilities to coordinate operational support activities within the QC Laboratory.

* Coordinate and maintain material management within the laboratory for consumables, reagents, and standards inventory.

* Coordinate and maintain sample management within the laboratory, including support for test scheduling and test turnaround time.

* Provide QC laboratory operational support, including instrument/equipment purchase, validation including software compliance, cleaning/maintenance requirements, monitoring and control.

* Author and review SOPs related to QC lab operations and provide QC input for cross-functional SOPs relating to general GMP operations.

* Work closely with Quality Assurance (QA) to support management of QC-related quality events, including change control, deviations and CAPA, and audit activities.

* Support purchasing and budgeting activities for QC laboratory operations.

* Other duties as required.

Minimum Requirements:

* Minimum of a Bachelor's degree in Biological Sciences or related field with a minimum of 3+ years of relevant experience in the industry is required OR a Master's degree with 1+ years relevant experience is required.

* Experience in Quality Control within the Biotechnology setting is a must, strong preference particularly for experience in Cell therapies in a cGMP-compliant environment.

* Highly familiar with laboratory operations, standard procedures and instrumentation, for testing of biologicals is preferred.

* Compliance mindset for the execution of elements within the quality system, including Change control, Deviation management, and CAPA implementation.

* Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).

* Excellent written and oral communication skills, with strong organizational skills, keen attention to detail and proven ability to be highly productive and successful in a high pace work environment.

* Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).

Work Environment

* In this position you will work in a controlled laboratory environment

* You may be periodically required to move heavy equipment around up to 50 lbs

* There is a risk of potential exposure to chemicals and biohazards consistent with somatic cell therapy culture

* Working in the laboratory requires mandatory use of personal protective equipment

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth 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. Everforth Apex uses a virtual recruiter as part of the application process.  for more details.

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