Quality Assurance Associate

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) helping 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.

We're proud of the impact we make and just last year, we supported over 780 discovery projects
, 1,000+ CMC programmes
, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers
. To learn more, visit

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 but not limited to;
  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 referenced 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 escalate 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

We're seeking individuals who have strong communication skills with attention to detail who thrive in fast-paced environments.

• Bachelor's degree in science, preferably in biology or 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

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China.

Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Pharmaron is a premier service provider for the life sciences industry... (continued text describing culture)

• 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
• 401k 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 Affluent 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.

#LI-JB1