Quality Assurance Specialist II (Part-Time)
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Job Location:
Durham County, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
For further inquiries regarding the following opportunity please contact our Talent Specialist:
Hema Malini at
Hema Malini at
Title: Quality Assurance Specialist II (Part-Time)
Duration: 6 months
Location: Research Triangle Park NC
Estimated Hours per Week: 30
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 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 Clients 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:
o 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:
o Laboratory and/or Quality Assurance experience in a laboratory setting.
o Audit experience desired
o 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.
o Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic flexible and constructive manner.
o Ability to prioritize organize work independently and multi-task among multiple projects and tasks simultaneously.
o Excellent interpersonal verbal and written communication skills.
o Proficiency in MS Word Excel PowerPoint and other applications
o Laboratory and/or Quality Assurance experience in a laboratory setting.
o Audit experience desired
o 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.
o Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic flexible and constructive manner.
o Ability to prioritize organize work independently and multi-task among multiple projects and tasks simultaneously.
o Excellent interpersonal verbal and written communication skills.
o 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.
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