Quality Assurance Associate

Adecco • Waltham, MA

407d • $93,600 - $97,032

About The Position

The Quality Assurance Associate position at Adecco involves ensuring compliance with quality standards in the pharmaceutical manufacturing process. The role focuses on reviewing and approving critical manufacturing documents, providing quality oversight, and supporting compliance with regulatory requirements. This contract position is essential for maintaining the integrity of drug substance and product quality in clinical trials.

Requirements

• Bachelor's degree and/or 8+ years of relevant experience.
• Minimum 5 years of experience in Quality Assurance.
• Working knowledge of Quality principles and cGMPs in a manufacturing, QA, or QC environment.
• Demonstrated ability to communicate effectively with peers, management, auditors, and consultants.
• Excellent attention to detail, project and time management skills, and ability to manage multiple priorities.

Nice To Haves

• Preferred experience with outsourced manufacturing and testing operations.
• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

Responsibilities

• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for GMP manufacturing activities.
• Perform QA review of Executed Batch Records.
• Perform QA review of Quality Records, including Deviations, CAPAs, and OOS.
• Perform QA review and approval on SOPs, forms, WI, and other document types.
• Provide SAP support for GMID and BOM approval.
• Provide Quality oversight and guidance to resolve compliance issues for drug substances and products.
• Ensure compliance with CMO Quality Agreements.
• Review and approve Analytical related documents such as Test Methods and Test Method Transfer Plans.
• Participate in Quality Risk Assessments.
• Assist with internal and external audits.
• Support data analysis and metrics for Quality Council and KPls.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short-term disability
• Additional voluntary benefits
• EAP program
• Commuter benefits
• 401K plan
• Paid Sick Leave
• Holiday pay

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree