Quality Assurance Associate III

6 days ago


Waltham, United States Randstad Life Sciences US Full time

1 Year Contract

Hybrid

Shift: Mon-Fri 8am-5pm or 9am-6pm


Job Responsibilities

• Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials

• Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.

• Ensure that all requirements, as stipulated in the appropriate QTA, have been met.

• Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur.

• Write and revise SOP, forms, WI, and any other document types

• Assist with internal and external audits.

• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.

• Assume additional responsibilities as assigned.

• Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.

• Write and revise SOP, forms, WI, and any other document types

• Assist with internal and external audits.

• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.


Education & Qualifications

• Bachelor’s and/or 8+ years of relevant experience

• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences)

• 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.


Must Have Experience:

• Bachelor’s and/or 8+ years of relevant experience

• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) – must be specific to pharm industry

• PHD may be considered overqualified


Nice to Have Experience:

• Investigation or product complaint experience



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