Quality Assurance Associate II (Scientific)

Company : RIT Solutions, Inc.

Country: United States

Location : Waltham, Massachusetts

Post: Fri, 24 Mar 2023 06:29:03 GMT

Expires: Fri, 21 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

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Job Description:

In this role you will:

• Reviews and approves master production records for the timely initiation of GMP manufacturing activities.

• 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

• SME for Quality in vendor meetings for raw materials, excipients, cell banks and plasmids

• 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 etc., as they occur.

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

• Assist with internal and external audits.

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

• Assume additional responsibilities as assigned.

Competencies / Requirements for position

About you

Qualifications/ Education & work experience

• Bachelor’s degree and/or 10+ years of relevant experience; Masters preferred

• Minimum 8 years of experience in Quality Assurance

• 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.