Analysis Skills, Assay Methods, Assays, Auditing, Best Practices, Business Strategy, Capability Maturity Model Integration (CMMI), Change Control, Clinical Laboratory, Clinical Practices/Protocols, Code of Federal Regulations, Communication Skills, Consulting, Corporate Compliance, Corrective Action, Cross-Functional, Customer Support/Service, Data Processing, Document Management, Documentation, Droplet Digital PCR (ddPCR), Equipment Validation, Establish Priorities, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), Healthcare, Interpersonal Skills, Laboratory, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Pre-Clinical Trials, Presentation/Verbal Skills, Problem Solving Skills, Professional Services, Quality Assurance, Quality Management, Regulations, Regulatory Requirements, Research Laboratory, Software Validation, Standard Operating Procedures (SOP), State Laws and Regulations, Team Lead/Manager, Team Player, Technical Support, Writing Skills
Research Triangle Park, NC
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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to learn more and view our open positions.Please apply or call one of us to learn more
For further inquiries about this opportunity, please contact one of our Talent Specialists, Remy at
(224) 394 4902
, (or) Hema Malini at (630) 847 0275
.
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 and 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 - Bachelor's 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.
Quality Assurance, GCP, SOP