QC Manager, Raw Materials

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.

• 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.

• Direct Reports:
  Yes
• Indirect Reports:
  None

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

• None

• 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 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

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

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