Quality Control Specialist II

Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of Ora Sure Technologies Inc. (OTI), and enables the democratization and decentralization of testing to personalize healthcare and make an impact on global health. OTIempowers 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, OTIprovides its customers with end-to-end solutions.

Here atOTIour innovative sampling tools for the genome and microbiome, and rapid diagnostics for infectious disease unlock access to accurate, essential information that advances global health and well‑being.

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 Ora Sure Technologies and regulatory bodies.

• 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 GLP 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 tools (e.g. Minitab).
• Orders and tracks inventory and supply items as needed.
• Learn new procedures in an appropriate timeframe 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 the 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 Ora Sure Technologies, Inc policies regarding attendance and punctuality. Respects the property of Ora Sure 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 Ora Sure Technologies activities.
• Cross‑functional work with R&D, QA, Operations.
• Supports Ora Sure Technologies, Inc policies and LIVEIT values (Lead with Integrity, Inspire Innovation, Value our Customers, Embrace Teamwork, Impact Success, Think Quality).

• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, One Drive, 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…