usa-quality assurance associate ii (scientific) - first shift

Randstad • Waltham, MA

418d • $93,600 - $99,091

About The Position

The Quality Assurance Associate II (Scientific) role is focused on ensuring compliance with quality standards in the manufacturing of pharmaceutical products. This position involves reviewing and approving critical documentation related to Good Manufacturing Practices (GMP), providing quality oversight, and supporting audits and quality risk assessments. The role is essential for maintaining the integrity of the manufacturing process and ensuring that all quality agreements are met.

Requirements

• Bachelor's degree and/or 8+ years of relevant experience.
• Minimum 5 years of experience in Quality.
• Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
• Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
• Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.

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 the timely initiation of GMP manufacturing activities.
• Perform QA review of Executed Batch Records.
• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.
• 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 Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.
• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
• Participate in Quality Risk Assessments.
• Assist with internal and external audits.
• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
• Assume additional responsibilities as assigned.

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution

What This Job Offers

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