Senior Specialist, Quality Assurance (Contract)

Braintree, MA | On-site | Contract (approx. 6 months) | $30-40/hr | 7 openings

About the Role

Be the quality voice on the floor. As a Senior Specialist, Quality Assurance, you'll work with minimal supervision on complex QA activities: reviewing and approving batch records and DHRs, supporting product disposition and release, and providing in-process quality oversight in the cleanroom. You'll also mentor junior QA staff and represent Quality in cross-functional work with Manufacturing, Engineering, and Quality Control.

All work is performed in line with QMSR (21 CFR Part 820), ISO 13485, and cGMP requirements.

What You'll Do

• Independently review and approve batch records and Device History Records (DHRs) for compliance and completeness
• Perform in-process quality reviews and approvals of critical manufacturing steps, and conduct cleanroom observations and risk-based spot checks
• Support and coordinate product disposition and release
• Provide advanced support for nonconformance investigations, CAPAs, root cause analysis, and effectiveness checks
• Support complaint investigations and post-market surveillance
• Review and approve validation and qualification documentation, and support process, test method, and equipment validations
• Support risk management activities, including pFMEA development and updates
• Write, review, and revise quality system procedures, forms, and controlled documents
• Lead activities in document control, change control, supplier quality, training compliance, and audit readiness
• Compile, analyze, and present quality metrics, and help prepare Quality Management Review materials
• Support and host portions of FDA inspections, internal audits, and external audits
• Train quality and manufacturing personnel, and mentor and coach junior QA staff
• Drive continuous improvement of the Quality Management System

What You Bring

Required

• Bachelor's degree in a science, engineering, quality, or related discipline (or an associate degree with equivalent relevant industry experience)
• 5-7 years of experience in Quality Assurance and/or Regulatory Compliance
• Demonstrated proficiency in QMSR / 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices
• Experience independently performing batch record review, DHR review, and product disposition and release
• Experience supporting nonconformance, investigation, and CAPA activities in a regulated environment
• Experience with change control and supporting process, test method, or equipment validations
• Experience conducting or supporting internal and external audits
• Working knowledge of Design Controls
• Proficiency with Microsoft Office and database systems
• Strong written and verbal communication, and the ability to work independently and cross-functionally
• Comfort working in cleanroom conditions and gowning into PPE

What will help you succeed

• Strong attention to detail across multiple simultaneous assignments
• Ownership mindset, with sound risk-based decision-making
• Flexibility when priorities shift, including additional hours when operations require it

Details

• Location: On-site in Braintree, MA
• Type: Contract, approximately 6 months
• Pay: $30-40/hr
• Openings: 7

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.