Job Description
This position is responsible for providing QA oversight and auditing 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:
Responsibilities & Accountabilities:
- Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of company laboratories
- 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.
- Quality Assurance Specialist - Bachelor’s degree, in 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 is a plus but not required.
- Laboratory and/or Quality Assurance experience in a laboratory setting.
- Audit experience, required
- Robust knowledge of immunogenicity (NAb and TAb) and ddPCR assays, required
- Strong collaborative skills. Must be able to 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
Numbers & Facts
| Location | Research Triangle Park, NC |
| Industry | Staffing/Employment Agencies |
| Salary | $33 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Assay Methodsunmatched
- Assaysunmatched
- Auditingunmatched
- Best Practicesunmatched
- Clinical Laboratoryunmatched
- Clinical Practices/Protocolsunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Corporate Complianceunmatched
- Cross-Functionalunmatched
- Document Managementunmatched
- Droplet Digital PCR (ddPCR)unmatched
- Establish Prioritiesunmatched
- GCP (Good Clinical Practices)unmatched
- GLP (Good Laboratory Practices)unmatched
- Healthcareunmatched
- Interpersonal Skillsunmatched
- Laboratoryunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Multitaskingunmatched
- Pre-Clinical Trialsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Research Laboratoryunmatched
- Standard Operating Procedures (SOP)unmatched
- State Laws and Regulationsunmatched
- Team Playerunmatched
- Writing Skillsunmatched
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