Position Title: Precision Medicine QA Associate
Work Location: 100% remote role & Preferable from East side
Assignment Duration: 6 Months
Work Schedule: 7:30 AM 4:30 PM EST
 
Position Summary:

• Provide operational and quality support across strategic initiatives and workstreams within Precision Medicine program team and PM QA.
• Collaborate with the PM QA lead to evaluate current QA processes, identify gaps, and co-drive improvement efforts to strengthen compliance, efficiency, and documentation standards.

 
Key Responsibilities:

• Facilitate cross-functional project management meetings, manage action tracking, and oversee project timelines and deliverables.
• Develop and maintain high-quality documentation, reports, and presentations for internal and external stakeholders.
• Support risk monitoring, audit readiness, and CAPA activities, ensuring alignment with global regulatory and GxP requirements.
• Contribute to broader CQA team initiatives and workstreams as needed.

 
Qualification & Experience:
Required:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
• 3-5 years of experience in Quality Assurance or Engineering within IVD, Medical Devices, or Diagnostics, including embedded software and manufacturing.
• Demonstrated experience in drug development, clinical trials, and diagnostic laboratory settings.
• Strong working knowledge of:

• 21 CFR 820 and 812
• ISO 13485, 14971, 15189
• CLIA, cGMP, GCP
• EU IVDR (In Vitro Diagnostic Regulation)
• Proficiency in audits, compliance documentation, and stakeholder engagement.
• ASQ CQE/CQA certification is advantageous.

 
Preferred Qualifications:

• Experience in GxP-regulated environments and familiarity with global regulatory frameworks (FDA, EMA, ICH).
• Proven ability to work effectively in matrixed and global team structures.
• Clinical QA experience is an added advantage

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 32.00/hr.