Quality Control Specialist

DNA Genotek, a part of Ora Sure Technologies Inc (OTI), develops products that optimize ease of collection and provide superior samples. DNA provides proven performance for those requiring high-quality biological samples for nucleic acid testing. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market. Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.

It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the Ora Quick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse. Overview DNA Genotek products are marketed worldwide and support thousands of customers as they achieve breakthroughs in genomic and microbiome research, in diagnostics laboratories, in the pharmaceutical industry, in companion animal genomics and in personalized medicine.

This job posting is to hire for a newly created position.

Snapshot of Responsibilities:

Perform all procedures accurately and according to written Work Instructions and SOPs as indicated in the Quality Control procedures and other applicable facility procedures.

Maintains a clean and organized work area.

Order supplies and manage stock levels of inventory needed to perform testing.

Assist in the training of Quality Control employees in new methods and procedures.

Develop and maintain systems to track trends in product and component quality.

Perform verification and calibration of certain measurement equipment.

Support process validations per procedures.

Responsible for performing inspection of labeling, finished product, raw materials and annual stability material.

Develop and maintain Quality Control related procedures.

Perform customer complaint and/or nonconformance investigations including additional testing, evaluations and record reviews when requested.

Advise Contract Manufacturers (CM) and other Suppliers on incoming lot acceptance results.

Plan with manufacturing and Supply Chain to organize shipment of stability samples within desired time frames.

Update and write stability reports summarizing test results.

Ability to work in laboratory environment (BSL1 and BSL2) which may include extended time in fume hoods.

Performs other job duties and special assignments and projects as put forth by the Quality Control Director/designee.

What You Bring:

Diploma in chemistry or biological science or equivalent combination of relevant job experience and training.

Education or certification in Quality Auditing, Quality Engineering or Quality Management an asset.

Minimum 3 years in a chemical laboratory environment.

Minimum 3 years in quality control or quality assurance role.

Meticulous attention to detail.

Strong laboratory and time management skills.

Experience analyzing technical data and preparing reports.

Knowledge of quality management systems such as ISO
9001, ISO
13485 or cGMP.

Experience with quality tools to solve problems.

Demonstrated resourcefulness and ability to work with a diverse set of tasks and responsibilities.

Proficiency in MS Office Applications.

OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong.

What we have…