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
Quality Assurance Specialist II Job Summary
Location: Research Triangle Park NC 27709
Job Type: Contract (182 Days) Bill Rate: $46.99/hr
Role Impact & Expectations:
The Quality Assurance Specialist II plays a critical role in ensuring the integrity compliance and continuous improvement of clinical and preclinical laboratory studies. This role directly impacts corporate adherence to national and international standards regulatory guidelines and industry best practices supporting the delivery of high-quality research outcomes. The position requires hands-on QA oversight systematic auditing and proactive identification and resolution of quality issues.
Key Skills Required:
- Laboratory QA
- Audit experience
- Immunogenicity assays
- ddPCR assay knowledge
- GCP GLP GCLP compliance
- 21 CFR Part 11 understanding
- Communication skills
- MS Word Excel PowerPoint
Key Responsibilities:
- Oversee and audit clinical and preclinical study activities for compliance with protocols SOPs and regulatory guidelines.
- Audit laboratory systems studies processes reports and records for accuracy and compliance.
- Conduct in-process inspections of nonclinical study phases and assay methodologies.
- Review study deviations investigations and change control documentation for adequacy and acceptability.
- Detect quality issues and assist management with corrective and preventive actions.
- Contribute to continual process improvement initiatives.
- Serve as a technical resource for compliance-related queries.
- Support SOP development implementation and maintenance.
- Perform other duties as assigned by Quality Assurance Management.
Recruiter Insights:
- High-impact role with significant responsibility in upholding quality and compliance in a dynamic research environment.
- Competitive contract rate and opportunity to work at a leading biotech hub.
- Ideal for candidates with robust laboratory QA and audit backgrounds who are skilled in immunogenicity and ddPCR assays.
- Exposure to advanced regulatory environments (GCP GLP GCLP).
- Nice-to-have: Prior GCP knowledge enhances candidacy but is not mandatory.
Candidate Insights:
- Opportunity to advance QA expertise within a reputable research organization.
- Gain exposure to cutting-edge laboratory techniques and global regulatory frameworks.
- Collaborate in a supportive quality-driven team environment.
- Develop skills in process improvement and compliance management.
- Enhance your career profile by contributing to essential quality oversight in clinical and preclinical research.
:
Location: Research Triangle Park NC 27709
Job Type: Contract (182 Days) Bill Rate: $46.99/hr
Role Impact & Expectations:
The Quality Assurance Specialist II plays a critical role in ensuring the integrity compliance and continuous improvement of clinical and preclinical laboratory studies. This role directly impacts corporate adherence to national and international standards regulatory guidelines and industry best practices supporting the delivery of high-quality research outcomes. The position requires hands-on QA oversight systematic auditing and proactive identification and resolution of quality issues.
Key Skills Required:
- Laboratory QA
- Audit experience
- Immunogenicity assays
- ddPCR assay knowledge
- GCP GLP GCLP compliance
- 21 CFR Part 11 understanding
- Communication skills
- MS Word Excel PowerPoint
Key Responsibilities:
- Oversee and audit clinical and preclinical study activities for compliance with protocols SOPs and regulatory guidelines.
- Audit laboratory systems studies processes reports and records for accuracy and compliance.
- Conduct in-process inspections of nonclinical study phases and assay methodologies.
- Review study deviations investigations and change control documentation for adequacy and acceptability.
- Detect quality issues and assist management with corrective and preventive actions.
- Contribute to continual process improvement initiatives.
- Serve as a technical resource for compliance-related queries.
- Support SOP development implementation and maintenance.
- Perform other duties as assigned by Quality Assurance Management.
Recruiter Insights:
- High-impact role with significant responsibility in upholding quality and compliance in a dynamic research environment.
- Competitive contract rate and opportunity to work at a leading biotech hub.
- Ideal for candidates with robust laboratory QA and audit backgrounds who are skilled in immunogenicity and ddPCR assays.
- Exposure to advanced regulatory environments (GCP GLP GCLP).
- Nice-to-have: Prior GCP knowledge enhances candidacy but is not mandatory.
Candidate Insights:
- Opportunity to advance QA expertise within a reputable research organization.
- Gain exposure to cutting-edge laboratory techniques and global regulatory frameworks.
- Collaborate in a supportive quality-driven team environment.
- Develop skills in process improvement and compliance management.
- Enhance your career profile by contributing to essential quality oversight in clinical and preclinical research.
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