Senior QA Specialist - On-site Contract (6 months)

SRG; Braintree (MA); Sur place; USD 62 000 - 83 000; Plein temps

Résumé du poste

Impellam Group is seeking a Senior Specialist, Quality Assurance for an on-site contract in Braintree, MA. You will lead complex QA activities, review batch records and DHRs, and mentor staff while ensuring compliance with QMSR, 21 CFR Part 820, ISO 13485, and cGMP.

Responsibilities include product disposition, nonconformance investigations, audits, risk management, and preparing QA metrics. Strong documentation and cross-functional collaboration are required.

Qualifications

• Bachelor's degree in a science, engineering, quality, or related discipline.
• 5-7 years of experience in Quality Assurance and/or Regulatory Compliance.
• Proficiency in QMSR / 21 CFR Part 820, ISO 13485, cGMP, and Good Documentation Practices.
• Experience reviewing batch records, DHRs, and product disposition and release.
• Experience supporting nonconformance, investigation, and CAPA activities.
• Experience with change control and validations (process, test method, equipment).
• Experience conducting internal and external audits.
• Knowledge of Design Controls.
• Proficiency with Microsoft Office and database systems.
• Strong written/verbal communication and ability to work cross-functionally.
• Comfort working in cleanroom conditions and PPE.

Responsabilités

• Independently review and approve batch records and DHRs for compliance.
• Perform in-process quality reviews and cleanroom observations.
• Support product disposition and release processes.
• Provide advanced support for nonconformance investigations and CAPAs.
• Support complaint investigations and post-market surveillance.
• Review and approve validation/qualification docs and support validations.
• Assist risk management activities including pFMEA and updates.
• Write and revise quality system procedures and controlled documents.
• Lead document control, change control, supplier quality, and audit readiness.
• Compile and present quality metrics and prepare management review materials.
• Support FDA inspections and internal/external audits; train staff.

Connaissances

Quality assurance

Regulatory compliance

Audits

Documentation practices

Risk management

Independent work

Cleanroom gowning

Formation

Bachelor's degree in science/engineering/quality

Associate degree with equivalent experience

Outils

Microsoft Office

Database systems

Description du poste

Impellam Group is seeking a Senior Specialist, Quality Assurance for an on-site contract in Braintree, MA. You will lead complex QA activities, review batch records and DHRs, and mentor staff while ensuring compliance with QMSR, 21 CFR Part 820, ISO 13485, and cGMP.

Responsibilities include product disposition, nonconformance investigations, audits, risk management, and preparing QA metrics. Strong documentation and cross-functional collaboration are required.