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

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.