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: 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.
