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 / 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.
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).
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.
EducationBachelors/Undergraduate degree (quality or science discipline preferred) 3+ years previous GMP laboratory experience.
Physical Requirements
Ability to work in an office / lab environment and to use appropriate equipment. Occupational exposure to bloodborne pathogens.Ability to perform general mobility functions (e.g., sitting, standing, lifting, carrying, reaching, bending, stretching, twisting, turning) with the ability to lift, tug, or pull up to 50lbs. Ability to sit or stand for extended periods of time - up to 4 hours at a time.
TRAVEL REQUIREMENTS
Job location is Oxford, UK. Additional limited travel upon request may be required for meetings, training, audits, or collaboration with other company locations or external partners.
COMPETENCIES
Quality Control Procedures: Proficiency in executing quality control procedures, including sample testing, data collection, and analysis, to ensure that products or processes meet established quality standards. Document Review and Compliance: The ability to review and verify documents, records, and reports for accuracy, completeness, and compliance with quality control protocols and regulatory requirements. Attention to Detail: Strong attention to detail to identify discrepancies, defects, or deviations in products or processes, ensuring that quality standards are met. Data Analysis and Reporting: Competency in collecting, analyzing, and reporting quality data, as well as the ability to generate reports that provide insights into quality control outcomes and trends. Problem-Solving and Troubleshooting: Effective problem-solving skills to identify quality issues, investigate root causes, and implement corrective actions to enhance product or process quality. Experience with molecular biology techniques (qPCR or other amplification reactions). Familiarity with lateral flow immunoassay principles (nitrocellulose membranes, pads, conjugates) and components (sample, conjugate, test, control, absorbent pads). Skill in using positive/negative controls and an understanding how to optimize assays for sensitivity and specificity. Experience with precision dispensing, cutting, and running assays. Solid understanding of biology, chemistry, immunology, and biomedical sciences. Experience in diagnostics, IVD (In Vitro Diagnostics), or clinical lab settings is highly valued. Molecular diagnostics preferred.
ORGANIZATIONAL RELATIONSHIPS / RESPONSIBILITIES
This position reports to Quality Control leadership.
Reformation
Spacex
Cookunity