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 / OBJECTIVE Quality Control Specialist II personnel perform procedures that include evaluation of raw materials, in-process samples, finished products, stability testing, and lab equipment maintenance and troubleshooting in compliance with guidelines established by OraSure Technologies and regulatory bodies.
Responsibilities
* Performs all procedures accurately and according to written work instructions (WIs) and standard operating procedures (SOPs) as applicable to the Quality Control department.
* Performs testing including raw materials, in-process samples, finished products, and stability programs. Performs customer complaint investigations including required testing and reporting.
* Supports and performs failure investigations and reports on findings with guidance.
* Actively participates in manufacturing/engineering studies and validation protocols. Completes all paperwork according to cGLP and cGMP guidelines.
* Maintains a clean, organized work area and keeps supplies stocked at the bench. Assists in updating work instructions (WIs) and other associated documents.
* Assists in the training of Quality Control employees in new methods and procedures and ensures continued compliance within the lab.
* Conducts and writes reports on product stability testing. Maintains systems to track trends in product and material quality.
* Identifies and reports on positive and negative product quality trends through trend analysis using statistical analysis tool (e.g. Minitab).
* Orders and tracks inventory and supply items as needed.
* Learn new procedures in an appropriate time frame and maintain competency.
* Effectively prioritizes workload in response to production needs.
* Recognizes and troubleshoots quality or equipment issues and notifies the Quality Control Supervisor or designee.
* Notifies the Quality Control Supervisor or designee of any nonconforming product according to the Corrective and Preventive Action System (CAPA).
* Demonstrates a cooperative attitude when performing duties within Quality Control department and in conjunction with other departments.
* Displays positive working relationships and cooperates with work assignments in the best interest of the department.
* Suggests constructive changes where needed using appropriate means of problem solving.
* Refer all complaints to the Quality Control Supervisor or designee.
* Consistently follows OraSure Technologies, Inc policies regarding attendance and punctuality. Respects the property of OraSure Technologies, Inc and other employees.
* Notifies Quality Control Supervisor or designee of equipment and/or procedural problems.
* Performs other job duties and special assignments and projects as put forth by the Quality Control Supervisor or designee.
* Maintains confidentiality with regards to OraSure Technologies activities.
* Cross functional work with R&D, QA, Operations,
* Supports OraSure Technologies, Inc policies and LIVEIT values (Lead with Integrity, Inspire Innovation, Value our Customers, Embrace Teamwork, Impact Success, Think Quality).
Requirements
* Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, OneDrive, and Teams.
* Strong planning, organizational, and time management skills
* Ability to consistently follow quality and safety protocols.
* Self-motivated and able to work independently and within a team environment.
* Well-developed communication skills both written and oral
* Flexible and able to work overtime as needed.
* Education
* Bachelors/Undergraduate degree (quality or science discipline preferred)
* 3+ years previous GMP laboratory experience.
£25,000 - £45,000 a year 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.