Senior Quality Specialist

Hw3 Llc; Boston (MA); On-site; USD 56,000 - 95,000; Full time

Job summary

Hw3 Llc in Boston, MA is seeking an experienced QA professional to lead quality activities in a GMP pharmaceutical/biotech setting on a 12-month contract, with extension possible up to 3 years. Up to $69 per hour (W2).

The role covers deviations, CAPA, change control, batch release support, and ensuring GMP compliance across manufacturing, QA and validation teams. Strong communication and regulatory knowledge required (FDA/EMA).

Qualifications

• 5+ years in GMP pharma/biotech QA environment.
• Strong experience with deviations, CAPA, and change control.
• Experience supporting manufacturing or commercial operations.
• Solid knowledge of GMP, FDA/EMA regulations, and quality systems.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead and support quality activities including deviations, CAPAs, change controls and investigations.
• Review and approve GMP documentation, procedures and quality records.
• Support batch release, product quality and manufacturing activities.
• Collaborate with Manufacturing, Engineering, Validation and QA to ensure GMP compliance.
• Provide guidance on quality standards, processes and regulatory requirements.
• Support continuous improvement and timely resolution of quality issues.

Skills

GMP knowledge

QA experience

Deviations handling

CAPA management

Change control

Regulatory compliance

Stakeholder management

Job description

• 12 month initial contract - Extention likely up to 3 years
• Up to $69 per hour - W2 Only

Key Responsibilities:

• Lead and support quality activities including deviations, CAPAs, change controls and investigations.
• Review and approve GMP documentation, procedures and quality records.
• Support batch release, product quality and manufacturing activities where required.
• Work closely with Manufacturing, Engineering, Validation and QA teams to ensure GMP compliance.
• Provide guidance on quality standards, processes and regulatory requirements.
• Support continuous improvement and ensure timely resolution of quality issues.

Requirements:

• 5+ years' experience within a GMP pharmaceutical/biotech environment.
• Strong experience across QA, deviations, CAPA and change control.
• Experience supporting manufacturing and/or commercial operations is highly desirable.
• Strong knowledge of GMP, FDA/EMA regulations and quality systems.
• Excellent communication and stakeholder management skills.