Quality Assurance Specialist
Job Location:
Durham County, NC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
For further inquiries regarding the following opportunity please contact our Talent Specialist Hema at 630.847.0275
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 - Bachelors 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 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
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
