Full-Time
Quality Assurance Specialist 4
Integrated Resources
501-1,000 employees
No salary listed
New Haven, CT, USA
In Person
 QA & Testing (1) |
|---|
- Minimum of 9 years of experience pharmaceutical or biotechnology drug development experience
- Experience managing clinical quality activities and knowledge of clinical operations
- Comprehensive knowledge of all pertinent regulations
- Education: Bachelor's degree required
- Languages: English Read Write Speak
- Develop and implement quality management plan for each assigned program
- Interpret and provide key metrics to Global Development Team Leader and cross-functional development team members
- Support GCP SOP development and serve as quality operations reviewer
- Execute risk-based methodologies for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan – Do – Check – Act
- Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development. Ensure timely implementation and closure of CAPAs.
- Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations. Ensure timely review and closure of quality issues.
- Assure appropriate escalations and notification to line management
- Lead inspection readiness and inspection preparation activities, including SME training/preparation and back room activities, and manage back room during GCP inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program. Provide lessons learned after each GCP inspection.
- Use knowledge of GCP, clinical development, and industry best practices in order to provide guidance, training and input to business partners on compliance issues. Able to adapt precedent and develop creative and effective solutions to solve problems.
- Masters preferred
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.