Quality Assurance Technician

Quality Assurance Technician

The Quality Assurance Technician verifies and approves Quality Control (QC) data, reviews batch records, and supports the verification of patient records to ensure compliance with GMP and ISO standards. This role works closely with the QA team to maintain accurate documentation, manage Trackwise entries, and support a growing product line within a regulated pharmaceutical or biotech environment.

Responsibilities

• Verify and approve Quality Control (QC) data accurately and in a timely manner.
• Review batch records thoroughly and ensure a complete and accurate chain of custody for all materials and documentation.
• Enter document reviews into Trackwise and maintain up-to-date and accurate Excel documentation.
• Support the verification process of all patient records, ensuring completeness, accuracy, and compliance with applicable standards.
• Perform detailed QC data review and clinical documentation review in alignment with internal procedures and regulatory requirements.
• Apply knowledge of GMP and ISO standards to daily QA activities and documentation practices.
• Utilize SAP and D365 to support quality assurance processes, data tracking, and documentation.
• Contribute to quality assurance testing activities and help identify, document, and escalate quality issues as needed.
• Collaborate with the QA team to support continuous improvement of quality systems and processes.
• Ensure all work aligns with established quality procedures, regulatory expectations, and internal policies.

Essential Skills

• Proficiency in quality assurance and batch record review.
• Hands-on experience with QC data review and clinical documentation.
• Demonstrated knowledge of GMP requirements and ISO standards.
• Experience using Trackwise for document reviews and quality workflows.
• Ability to maintain and manage Excel documentation accurately.
• Familiarity with SAP and D365 in a quality or manufacturing environment.
• Associate or Bachelor of Science (BS) degree in a life science discipline.
• 1–3 years of relevant pharmaceutical or biotech experience.
• Strong attention to detail and ability to identify discrepancies in documentation.
• Ability to work effectively as part of a QA team and follow established procedures.

Additional Skills & Qualifications

• Very knowledgeable in working under GMP requirements within a regulated environment.
• Experience with quality assurance testing and related QA activities.
• Comfort working with electronic quality systems such as Trackwise.
• Ability to manage multiple documentation tasks and priorities simultaneously.
• Interest in gaining exposure to new product lines and expanding QA expertise.
• Strong written and verbal communication skills for clear documentation and collaboration.

Work Environment

The Quality Assurance Technician works 100% within the QA team and follows a Tuesday–Saturday schedule, providing consistent support during core operational days. The role requires regular travel between sites in Cambridge and Burlington, so candidates should be comfortable commuting between these locations as part of their weekly routine. The environment is a regulated pharmaceutical or biotech setting that operates under GMP and ISO standards, using systems such as Trackwise, SAP, D365, and Excel to manage quality documentation and workflows. Team members gain exposure to a new product line and have the opportunity to run a significant portion of QA work, contributing directly to the reliability and compliance of critical processes.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $30.00 - $40.00/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)

Application Deadline

This position is anticipated to close on Aug 7, 2026.