Quality Assurance Specialist II - Triangle, NC

Job Description · About the role · This position is responsible for providing QA oversight and auditing of activities related to clinical and preclinical studies. Examples of activities within the scope of oversight and auditing include but is not limited to: preclinical animal s ...

Job description

Job Description
About the role

This position is responsible for providing QA oversight and auditing of activities related to clinical and preclinical studies. Examples of activities within the scope of oversight and auditing include but is not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Studies may be performed in-house or at a contract research facility. This role will assure corporate compliance with applicable GCP, GLP, GCLP national, international, and state regulations and guidelines. This position will report to the Quality Assurance Manager (GCP/GLP).

Responsibilities & Accountabilities

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of company laboratories, vivarium, vendors and CROs.
• Audit systems, studies, processes, reports, records, and data for accuracy and compliance with applicable regulations. Follow up on any audit findings.
• Perform in-process inspections of nonclinical study phases and assay methods.
• Review study events, deviations, investigations, and change control documentation to assess acceptability of content and documentation.
• Detect Quality Issues and assist Quality Assurance Management with corrective and preventative action process.
• Participate in improvement initiatives intended to improve quality, study compliance, processes, study data, and reports.
• Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues.
• Contribute to the development, implementation, and maintenance of SOPs.
• Support the coordination and management of regulatory agency inspections, parent company audits, etc.
• Participate in the vendor qualification program to ensure Sponsor Oversight of vendors.
• Participate in meetings as a quality lead, as requested.
• Other duties, as assigned by Quality Assurance Management.
• Occasional light travel may be expected to perform audits (~10%).

About You

• Education/ Qualifications:
• Quality Assurance Specialist - Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
• Knowledge: Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, a solid understanding of 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research). Knowledge of GCPs a plus, but not required.
• Experience, skills, and characteristics:
• Laboratory and/or Quality Assurance experience in a laboratory setting.
• Audit experience, desired
• Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team.
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
• Ability to prioritize, organize, work independently, and multi-task among multiple projects and tasks simultaneously.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Word, Excel, PowerPoint, and other applications

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.