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CTM Associate (Clinical Trial Manufacturing)

Holly Springs, NC 27540

Posted: 04/08/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 603321 Is job remote?: No Country: United States

Job Description

Target PR Range: 23-33/hr
*Depending on experience

Job Description:

The CTM (Clinical Trial Manufacturing) Associate will be responsible for supporting cGMP readiness and tech transfer activities of early phase clinical trial manufacturing processes. The associate would support the following:
• Authoring/owning cGMP documentation (SOPs, Batch Records) and technical documentation (Gap Assessments, FMEA Assessments, Technical Protocols/Reports, etc.) This function involves creating, revising, and withdrawing documentation, including ownership of related compliance actions.
• Ownership and/or execution of Change Controls (CCs)
• Provide support for generation of SAP material codes and creation of BOM (bill of materials) builds
• Support manufacturing activity for development batches and tech transfer batches
• Support equipment qualification activities

Following Tech Transfer the CTM associate will be responsible for activities to produce cGMP batches which includes:
• cGMP manufacturing (Drug Substance and Drug Product)
• Using SAP for GMP material inventory management (issuance/receiving of materials, cycle counting)
•Ownership/execution of quality based workflows (Deviations/CAPAs). Investigation experience is a plus
• Maintain the CTM area in cGMP compliance, which includes executing routine PMs on process equipment, 5S (area organization and material inventory), and equipment logbook management
• Adherence to gowning requirements of classified areas

Minimum Required Qualifications:
• 1 year experience in pharmaceutical manufacturing, or another similarly regulated environment
• Demonstrated technical writing skills and manufacturing document ownership
• GMP experience preferred (entry level is ok)

Preferred Qualifications / Ideal candidate would have:
• Experience using SAP to manage inventory and work orders
• Experience using QMS software (quality mgmt. systems) such Veeva or Metricstream to own change controls, CAPAs and deviations
• Prior use of LIMS to build and manage sample plans and sample tracking
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