Quality Assurance Specialist

Contract position based in Norwood, MA. Intermediate level role.

About the role

Provide quality oversight for manufacturing operations, ensuring compliance with cGMP regulations and internal procedures.

Responsibilities

• Review and disposition raw materials, plasmids, drug substance, and drug product batches.
• Review and approve batch production records, testing records, and manufacturing documentation.
• Support batch record review and release activities for materials and products.
• Review, investigate, and document deviations, ensuring appropriate corrective and preventive actions are implemented.
• Author, review, and revise SOPs, batch records, policies, and training materials.
• Participate in real-time quality oversight activities within manufacturing operations and cleanroom environments.
• Partner with cross-functional teams to support manufacturing readiness, startup activities, and continuous improvement initiatives.
• Ensure adherence to data integrity principles and training requirements.
• Monitor manufacturing operations for compliance with established specifications and procedures.
• Support internal audits and regulatory inspection readiness activities.
• Escalate quality, manufacturing, and safety concerns as appropriate.
• Serve as a subject matter expert (SME) and mentor for new team members.
• Lead and contribute to quality and compliance-related projects across multiple functional groups.
• Drive root cause investigations and corrective actions for complex quality issues.

Requirements

• BS or equivalent experience in the science industry within quality assurance.
• 2-5 years of experience.
• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
• Experience with quality systems, including batch record review, deviation management, and change control.
• Proficiency in authoring and reviewing GMP documentation.
• Familiarity with environmental monitoring and microbiological testing.

Skills

• Quality assurance
• Drug substance and drug product oversight
• Batch record review and approval
• Raw materials disposition
• Deviation investigation and documentation
• Change control management
• Environmental monitoring
• Microbiological testing
• SOP authoring and revision
• Audit and compliance support

Pay

$42.00 - $52.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance
• Critical illness, accident, and hospital insurance
• 401(k) retirement plan (pre-tax and Roth post-tax contributions available)
• Life insurance (voluntary life and AD&D for employee and dependents)
• Short- and long-term disability
• Health spending account (HSA)
• Transportation benefits
• Employee assistance program
• Time off/leave (PTO, vacation, or sick leave)

Schedule

Fully onsite position in Norwood, MA.