Quality Assurance Specialist II
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Job Location:
Durham County, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
For further inquiries about this opportunity please contact one of our Talent Specialists Remy at (or) Hema Malini at .
Title: Quality Assurance Specialist II
Duration: 6 Months
Location: Research Triangle Park NC
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Job Description
- 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).
Responsibilities & Accountabilities
- Assess and assure study project and process compliance with protocols controlled documents and applicable regulations and guidelines through audits of Client 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 - 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 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
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.
