QA Contractor, GMP Quality Assurance

DivIHN Integration Inc; Durham (NC); On-site; USD 75,000 - 90,000; Full time

Job summary

DivIHN Integration Inc in Durham, NC, is seeking a Quality Assurance Specialist to provide oversight and auditing of clinical and preclinical studies. You will ensure compliance with Good Clinical Practices and other regulations while collaborating with technical staff.

The ideal candidate holds a Bachelor’s degree in a scientific field with at least 3 years of relevant experience. Strong skills in auditing and organizational abilities are essential for this role, based onsite in Research Triangle Park.

Qualifications

• Bachelor’s degree in a related field and 3+ years of industry experience.
• Knowledge of Good Clinical Laboratory Practice and Good Laboratory Practice regulations.
• Experience with immunogenicity assays is essential.

Responsibilities

• Audit studies, processes, and data for compliance with regulations.
• Perform in-process inspections of nonclinical study phases.
• Act as a technical resource for compliance-related issues.

Skills

Audit experience

Collaborative skills

Organizational skills

Interpersonal communication

Education

Bachelor's degree in a health care or relevant scientific field

Tools

MS Word

Excel

PowerPoint

Job description

Location: Onsite at Research Triangle Park, NC

Duration: 6 Months

Hours: Monday to Friday (30 hours per week)

Only W2 candidates are eligible for this position. Third‑party or C2C candidates will not be considered

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 are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, 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).

Responsibilities & Accountabilities

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of client
• Audit 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.
• Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance‑related issues.
• Other duties, as assigned by Quality Assurance Management.

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 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, required
• Robust knowledge of immunogenicity (NAb and TAb) and ddPCR assays is 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 multitask among multiple projects and tasks simultaneously.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Word, Excel, PowerPoint, and other applications.