Quality Control Specialist

DNA Genotek, a part of OraSure 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 OraQuick® 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 an existing vacancy.
Quality Control Specialist personnel executes written procedures that include evaluation of raw materials, finished products, equipment and product performance in compliance with guidelines established by OraSure Technologies and regulatory agencies.

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 timeframes.
• 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 ISO9001, ISO13485 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 to offer: - Highly competitive Health, Dental and Vision Coverage for you, your spouse and your dependents - Disability and Life Insurance Benefits - RRSP plan with company-matching contributions - Generous paid time-off, including vacation days, sick days, additional company wide paid days off and personal days - Maternity Leave and Parental Leave Coverage - Adoption benefit for parents adopting a child - Employee Referral Program– you may be eligible for a cash bonus if your referrals are hired - Employee Assistance Program - Employee Service Recognition - Annual Fitness Reimbursement - Job-related Training Programs - Ability to participate in Teams, Committees, Events and Clubs - Depending on the role you may be eligible to work in a hybrid environment or fully remotely - Free Onsite Parking Please note, the above applies to full-time permanent positions. Culture, People & Community OTI recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and OTI employees. As such, we have committees designed to address this, including: - LIVE IT Committee – committed to creating an environment that embodies our values - All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book club and a mentorship program - Wellness Committee empowers colleagues to make critical decisions to improve and protect health - Sustainability Committee aims to minimize impact on the environment - Social Committee who organize and run events for both remote and onsite employees, to create connection and community At DNA Genotek, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of citizenship, race, place of origin, ethnic origin, colour, ancestry, disability, age, creed, sex/pregnancy, family status, marital status, sexual orientation, gender identity, gender expression, and record of offences (in employment), or any other characteristic protected by law with regard to any employment practices. OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Lauren Gray at lauren.wildfang@dnagenotek.com. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.