POSITION OBJECTIVE: Manage Incoming Quality Control (IQC) personnel and related inspection programs. Oversee IQC metrics, inspections and release of incoming materials, investigations, and continuous improvement of the department.

Essential Job Functions/Responsibilities

• Oversee incoming quality control of raw materials, consumables, critical reagents, components, and bulk packaging/labeling for pharmaceutical manufacturing sites.
• Oversee sampling of raw materials for QC laboratory testing and release for production use.
• Setup and maintain efficient IQC systems and processes for increasing pharmaceutical manufacturing output and additional sites/locations.
• Provide cGMP guidance and training to IQC personnel.
• Ensure IQC areas are in state of compliance and are inspection ready for regulatory agencies audits.
• Ensure a safe work environment for personnel with compliance to OSHA requirements.
• Recruit, manage, and schedule of personnel to meet manufacturing and QC laboratory needs.
• Conduct discrepancy and failure investigations and process applicable MRDRs and CAPAs in a timely manner.
• Manage departmental budget planning including equipment and instrument purchases to support efficient processes. 
• Create, revise, and/or review operational SOPs, technical documents, protocols, and reports.
• Establish and promote staff engagement, motivation, and personnel development through coaching and mentorship. 
• Complete staff assessments and performance reviews as required ensuring competencies are maintained.
• Participate in personnel development programs to further enhance skills and knowledge relevant to the position.
• Provide input into continuous improvement and KPI metrics development and maintenance.
• Serve as SME and provide guidance for IQC development, area inspections and compliance, and follow up actions and responses as Provide support for customer and manufacturing related needs while maintaining a high level of professionalism.
• Manage and support production needs that occur on off-shift hours.
• Perform other related duties and responsibilities as assigned.