QC Manager, Raw Materials

MedPharm
Durham, NC

Position Summary – The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients

 

Essential Functions

  • Author or act as author for lab investigations, deviations, protocols and specifications for raw materials.
  • Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
  • Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
  • Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
  • Interact with third party laboratories for microbial and analytical testing of raw materials
  • Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
  • Create purchase requisitions for lab supplies and third-party testing
  • Perform weekly laboratory audit inspections
  • Perform sampling of raw materials as needed
  • Review third party laboratory investigations and protocols.
  • Provide technical support to the laboratory for method and instrument troubleshooting as needed.
  • Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques.
  • May perform testing of raw materials, packaging components, and other samples as needed.
  • Other duties as assigned

Supervisory responsibilities :

  • Direct Reports: Yes
  • Indirect Reports: None

Key Relationships:

  • Manufacturing Operations
  • Quality Assurance
  • Analytical R&D
  • Program Management

Travel requirements :

  • None

Education and Experience

  • Minimum BA or BS in a scientific discipline required
  • Minimum of 5 years of prior supervisory experience.
  • Minimum 5-7 years in an Analytical development or Quality Control setting for Pharmaceutical Products or Raw Materials preferred
  • Experience establishing and maintaining relationships with key decision makers

Knowledge, Skills, and Abilities

  • Knowledge of cGMPs
  • Good communication, organization and computer skills are required.
  • Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired.
  • Ability and willingness to work additional hours as required by business need
  • At least 5 years’ experience in a CRO environment
  • Experience with USP, EP and JP monographs.
  • Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size.
  • Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
  • Excellent verbal and written communication skills
  • Ability to work with minimal supervision
  • Experience in Data Review of Analytical data per GDP guidelines.
  • Proven ability to review and evaluate the compliance and completeness of analytical data.
  • Able to multi-task productively, applying time management processes and procedures effectively.
  • Works toward common goals by supporting, encouraging, and sharing information with colleagues.
  • Strong analytical skills and ability to understand business and financial implications of contracts
  • Self-directed

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

  • Requires frequent sitting and walking
  • Requires carrying under 20 LBS, occasionally 20 – 60 LBS
  • Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS
  • Requires occasional bending, twisting, reaching, & gripping
  • Requires constant seeing & hearing

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Posted 2026-01-21

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