Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: GCP Auditor, Quality Assurance
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 6+ Months
Work Type: Onsite
Shift: Mon-Fri 9.00 AM-5.00 PM
Shift: Mon-Fri 9.00 AM-5.00 PM
Job Description:
- The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance.
- This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits.
- This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.
- The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates.
- The ideal candidate will have extensive GCP experience.
- This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies.
- They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance
Requirements:
- 2+ years of pharmaceutical experience
- BS degree in scientific, health care or related discipline
- Intensive GCP and safety background
- Experience with both internal and external process and systems audits
- Strong knowledge of development policies, procedures and standards (SOPs, QMS)
- Ability to work with global clinical teams in developing objectives for audits of clinical studies
- 10% Traveling required
TASKS AND RESPOSIBILITIES:
- Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
- Plan and conduct audits of specific clinical processes based on risk.
- Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor.
- Develop audit reports and distribute them to appropriate stakeholders
- Own and manage related clinical vendor non-conformances.
- Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).
- Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
- Support the preparation, coordination, and participation of regulatory agency inspections.
- Participate in and support quality improvement projects.
- Candidates MUST HAVE 2+ years of radiopharmaceuticals and quality experience.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Paramus, NJ |
| Industry | Computer/IT Services |
| Salary | $50 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Auditingunmatched
- Biotech and Pharmaceuticalunmatched
- CMOSunmatched
- Calendar Managementunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Supportunmatched
- Clinical Trialunmatched
- Compuware QADirector Test Management Softwareunmatched
- Contract Research Organization (CRO)unmatched
- Corporate Complianceunmatched
- Cross-Functionalunmatched
- Diversityunmatched
- Drug Developmentunmatched
- Electronic Data Capture (EDC)unmatched
- External Auditunmatched
- FDA Requirementsunmatched
- GCP (Good Clinical Practices)unmatched
- GxPunmatched
- Healthcareunmatched
- Healthcare Qualityunmatched
- Information Technology/Systems Auditunmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Neurologyunmatched
- Pharmacovigilanceunmatched
- Policy Developmentunmatched
- Procedure Developmentunmatched
- Psychiatry and Mental Healthunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Reporting Skillsunmatched
- Riskunmatched
- Risk Managementunmatched
- Standard Operating Procedures (SOP)unmatched
- Team Playerunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Managementunmatched
- Vendor/Supplier Sourcingunmatched
- Willing to Travelunmatched
- Workforce Managementunmatched
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