Quality Assurance Specialist II

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 are 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. 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).

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of company laboratories
• 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.
• Other duties, as assigned by Quality Assurance Management.

Education/

Qualifications:

• Quality Assurance Specialist – Bachelor’s degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
• 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.

Laboratory and/or Quality Assurance experience in a laboratory setting.

• Audit experience, required
• Robust knowledge of immunogenicity and ddPCR assay, required
• 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.