Quality Assurance Associate

Pharmaron • Woburn, MA

54d • $65,000 - $75,000 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• ISO 9001:2015 Quality Systems experience, a plus
• Strong technical writing skills

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees