QC Manager, Raw Materials

MedPharm•Durham, NC

About The Position

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

Requirements

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
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

Responsibilities

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