The Role
The Quality Assurance Associate will ensure compliance with regulatory requirements for products, conduct document reviews, assist in quality events, and support continuous improvement of the Quality System.
Summary Generated by Built In
Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of OraSure Technologies Inc. (OTI), and enables the democratization and decentralization of testing to personalize healthcare and make an impact on global health. OTI empowers the global community to improve health and wellness by providing access to accurate, essential information. 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.
Overview
Here at OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.
SUMMARY
Individual will be responsible for performing quality assurance functions related to ensuring compliance to applicable FDA, ISO, and Canadian Medical Devices, and other country regulatory agencies requirements applied to currently approved products and products under development.
Essential Duties and Responsibilities
- Review and approve documentation for in-coming raw materials and manufactured products to ensure compliance with the Quality System requirements, including archiving of Device History Records, in accordance with established document retention policies
- Assist in quality events (CAPAS, root cause analysis, etc.)
- Participate in the preparation and review of documents and procedures supporting compliance to Quality System requirements
- Participate in evaluating Quality functions to ensure continuous improvement of the Quality System
- Other tasks as assigned
Qualifications
- Strong planning, organizational and time management skills
- Able to handle multiple projects simultaneously
- Attention to detail, and good problem-solving skills
- Self-motivated and able to work with minimum supervision
- Well-developed communication skills both written and oral
- Ability to work at least 40 hours in an office environment, flexible to work overtime as needed
- Ability to follow written and oral directions, good communication skills
- Ability to use office equipment
- Ability to perform general mobility functions (e.g., sitting, bending, standing, filing, light lifting)
- Any scientific degree with 0-2 years of experience in a regulated industry
- Well-developed PC skills, knowledge of Microsoft applications (Office, Excel, etc) or equivalent required
PHYSICAL REQUIERMENTS
EDUCATION AND/OR EXPERIENCE
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:
- Private Insurance – which includes supplemental health coverage and dental coverage
- Life Insurance Benefits
- Pension scheme
- Paid time off
- Maternity Leave and Parental Leave Coverage
- Employee Referral Program – you may be eligible for a cash bonus if your referrals are hired
- Employee Assistance Program
- Employee Service Recognition
- 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.
- 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 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 OTI, 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 sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, 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 Katheryn Viau at [email protected]. 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.
Skills Required
- Any scientific degree
- 0-2 years of experience in a regulated industry
- Well-developed PC skills
- Knowledge of Microsoft applications (Office, Excel, etc.) or equivalent
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The Company
What We Do
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers.
