Quality Control Specialist II

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.

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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.