Quality Assurance Manager

Company Overview

OpAns, LLC is an established contract research organization (CRO) specializing in mass spectrometry, separations chemistry, pediatric clinical trial support and micro‑sampling techniques (including use of our patented dried bio‑fluid specimen (DBS) collection device). Our services are divided into three support areas: research, development and forensic testing. We support government (EPA, NIH, NCATS), chemical industries (pharmaceuticals and agricultural chemicals), hospitals, clinics, and judicial systems.

Ideal candidates should have a strong background performing audits and managing quality issues within a regulated laboratory environment.

• Performance of audits and completion of corrective and preventive actions (CAPAs)
• Authoring / reviewing standard operating procedures (SOPs)
• Translation of complicated regulations/rules into clear and usable recommendations
• Strong written and verbal communication skills including good command of the English language, strong presentation, negotiating and networking capabilities
• Demonstrated ability to work in the fast‑paced environment like that of a growing company including effective problem solving, strategic thinking and conflict resolution
• Proficiency with administrative computer applications including Word, Excel, and PowerPoint and the ability to learn new software (as needed)
• Excellent organizational skills

• Experience with quantitative data acquisition and analysis software (e.g., Agilent Mass Hunter).
• A thorough knowledge of and experience working with and supporting computer system validations and Part 11 electronic records and signature requirements.

You’ll work with management and laboratory staff to provide state‑of‑the‑art analysis of biological specimens that will support the development of new drugs, support new uses of existing drugs, and monitor the use of drugs in a multitude of populations.

This position adheres to, maintains, and monitors the OpAns’ quality management system (QMS) documents (e.g., SOPs, templates, manuals and policies) assuring compliance with the applicable regulations (e.g., GLPs, Part 11, CLIA) and regulatory guidance (e.g., Bioanalytical Method Validation), including:

• Performance of audits (internal and external), review and approval (if applicable) of quality procedures, preparation for and hosting of inspections, monitoring of audit results for trends and advisement on improvements, documenting and completing of corrective and preventive actions (CAPAs) documentation including providing recommendations to ensure compliance is maintained.

You will also:

• Develop, review and revise (as needed) Quality Assurance Unit (QAU) SOPs in agreement with management.
• Work with management to ensure the availability of required capable resources for the QAU department.
• Collaborate and ensure open communication with other departments.
• Report to the quality leadership team.
• Ensure activities meet and integrate with organizational requirements for quality management, health and safety, legal stipulations, environmental policies and general duty of care, as directed and applicable.
• Support / provide QMS system training development and training activities, as needed.
• Assure strong long‑lasting relationships with key accounts and regulators.
• Support management in preparation of new proposals, as needed.
• Contribute and take part in client evaluations, visits and bid defenses, and other business as directed and applicable.
• Perform other duties as assigned.

Mid‑Senior level

Full‑time

Quality Assurance

Research Services

Durham, NC

$–$

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