Quality Assurance Specialist-raw Amterials

Quality Assurance Specialist II

Location:

Onsite, Norwood, MA

Schedule:

First Shift | Sunday–Wednesday

Industry: Biotechnology / Biopharmaceutical Manufacturing

We are seeking a Quality Assurance Specialist II to support GMP manufacturing operations through quality oversight, batch record review, materials disposition, documentation control, and quality systems management. This role will partner closely with Manufacturing, Quality Control, and cross-functional teams to ensure compliance with cGMP regulations, internal procedures, and regulatory requirements.

The ideal candidate will have experience in a regulated environment and a strong understanding of quality systems, batch record review, deviation management, and GMP documentation.

• Perform quality review and disposition activities for Plasmid, Drug Substance, and Drug Product manufacturing operations.
• Review and approve executed electronic and paper batch records to ensure compliance with cGMP requirements.
• Evaluate manufacturing deviations, investigations, and documentation to ensure adherence to quality standards and procedures.
• Provide real-time quality oversight of manufacturing operations, including observation of production activities and cleanroom practices.
• Author, review, and revise SOPs, policies, batch records, training materials, and other GMP documentation.
• Support raw material review, release, rejection, and destruction processes.
• Monitor manufacturing processes to ensure compliance with approved specifications and procedures.
• Identify, document, classify, and escalate quality events and deviations as appropriate.
• Participate in internal audits and support inspection readiness activities.
• Serve as a quality representative on cross-functional teams and quality-focused initiatives.
• Lead and manage projects from initiation through completion while collaborating with multiple stakeholders.
• Drive continuous improvement efforts that enhance compliance, quality, and operational efficiency.
• Support training compliance and promote adherence to data integrity principles.
• Act as a subject matter expert (SME) and mentor for new team members.
• Assist in root cause analysis, problem-solving efforts, and implementation of corrective and preventive actions (CAPAs).

• Bachelor's degree in a scientific discipline or equivalent combination of education and industry experience.
• 2–5 years of experience in biotechnology, biopharmaceutical, pharmaceutical, or another regulated industry.
• Experience in Quality Assurance, Quality Systems, Documentation Control, or a related quality function.
• Strong knowledge of cGMP regulations and quality system requirements.
• Experience reviewing GMP documentation, batch records, deviations, and investigations.
• Excellent organizational, communication, and problem-solving skills.

• Knowledge of FDA, EU, and ICH guidelines and regulatory requirements.
• Experience with quality systems including:
  Batch Record Review, Deviation Management, Change Control, CAPA Programs, Training Compliance.
• Familiarity with environmental monitoring and microbiological testing.
• Experience supporting manufacturing operations within a GMP production environment.
• Proven ability to lead cross-functional projects and manage multiple priorities simultaneously.

• Quality Assurance (QA)
• cGMP Compliance
• Batch Record Review
• Deviation Management
• Quality Systems
• Documentation Control
• Change Control
• CAPA
• Data Integrity
• GMP Documentation
• Manufacturing Quality Oversight
• Audit Support
• Project Leadership
• Training Compliance

Mid-Level (2–5 Years)

This is an excellent opportunity for a quality professional looking to expand their impact within a fast-paced biopharmaceutical manufacturing environment while helping ensure the highest standards of product quality, compliance, and patient safety.

Job Type &

Location:

This is a Contract position based out of Dedham, MA.

Pay and Benefits:

The pay range for this position is $42.00 - $52.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision;
Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available;
Life Insurance (Voluntary Life & AD&D for the 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).

Workplace Type:
This is a fully onsite position in Dedham, MA.

Final date to receive applications:
This position is anticipated to close on Aug 10, 2026.