Quality Assurance Associate

Quality Assurance Associate

Pharmaron

Position: Quality Assurance Associate

Location: Woburn, Boston – Onsite

Salary: $65,000 to $75,000 per year

FLSA Classification: Exempt

Pharmaron is a global CRO (Contract Research Organization) that helps pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

On the previous year we supported over 780 discovery projects
, 1,000+ CMC programmes
, and 1,000+ clinical trials across all phases. Our teams work across small molecules, ADCs, biologics, and gene therapies for more than 3,000 global customers
. Visit for more information.

The Quality Assurance Associate will work in a GxP compliant Bioanalytical CRO Laboratory and will be responsible for daily QA duties under the supervision of the Lead Quality Specialist. This onsite role will support the development, implementation, and maintenance of the Pharmaron (Boston) Lab Services Quality Management System.

• Perform administrative and support tasks to assist PLSB Head of Quality in maintaining all key Quality Systems including;
  Document Control, Training and Qualification Management, Deviation and CAPA Management, Audits and Inspections, Equipment Qualification and Management, Archival and Records Management, and tracking and trending.
• Perform initial intake, documentation, notification, administrative review, tracking, filing, and completion support for records related to the above quality systems.
• Ensure all records are indexed, labeled, tracked, and filed appropriately in paper and electronic format.
• Maintain robust cross-referencing tracking tools with required information to support Head of Quality review of trends, risks, issues, and gaps.
• Provide reports to Lead Quality Specialist of upcoming, outstanding, and incomplete tasks and events.
• Support PLSB technical and laboratory staff in navigating basic QA procedures and escalating issues to Head of Quality when appropriate.
• Assist Head of Quality on all assigned projects, including reconciliation and organization of legacy information for increased accuracy, reduced error, closure of historical gaps, and ease of access.
• Additional duties, as required

• Bachelor's degree in science, preferably in biology or a similar field (preferred)
• Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
• ISO 9001:2015 Quality Systems experience, a plus
• Strong technical writing skills

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer‑funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer‑paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401(k) plan with generous employer match
• Access to an Employee Assistance Program

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and affirmative action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.