Randstad Life Sciences US | Quality Assurance Associate II | waltham, ma

2 days ago

waltham, United States Randstad Life Sciences US Full time

1 Year Contract

Waltham, MA (Hybrid - Flexible Days)

PR: $42-47/hour


Schedule: Monday-Friday, 8am-4pm or 9am-5pm (some flexibility with hours).

Job 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.


Education & Qualifications

• Bachelor's 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.

• Must have excellent attention to detail, project and time management skills, and the ability to

manage multiple priorities with aggressive timelines.

• Preferred experience with outsourced manufacturing and testing operations

• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

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