Quality Assurance Associate II (Pharma GMP) (s487)

  • Contract Duration: 11+ months, Hybrid
  • Manufacturing
  • Waltham, MA

Website Lenox Executive Search

Job description

Lenox Executive Search is seeking an experienced Quality Assurance Associate II (Pharma GMP) to fill a 11+ month contractual, Hybrid position with a leading global pharmaceutical company. In this role you will review and approve master production records for the timely initiation of GMP manufacturing activities.

RESPONSIBILITIES of the Quality Assurance Associate II:
• Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substances, 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.

REQUIREMENTS for the Quality Assurance Associate II:
• 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.

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As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
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  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
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– The Lenox Executive Search Team