Manager, Incoming QC - Chemicals

Description

Position Summary & Responsibilities:

Manage and provide leadership for the Analytical Chemistry Incoming Quality Control Team and ensure appropriate capabilities, resources, and processes are developed, implemented, monitored and maintained. The QC Manager is tasked with oversight of sophisticated chemistry techniques, oversight and execution of chemical product testing, including testing of raw materials, in-process and semi-finished materials. This position involves working cross functionally to develop the strategic functional capabilities needed to support the department and site responsibilities.

• Manage chromatography chemists for compendial testing in a cGMP/GLP environment. Manage and conduct investigations for OOS results, errors and deviations.
• Manage incoming inspections, in-process inspections, and analytical/physical testing of materials. Support the production of Micro-Use Test cards for testing of incoming chemicals.
• Develop and implement HPLC Analytical Test Methods and new Analytical Technology. Develop and implement incoming inspection, physical/analytical testing, and operational procedures.
• Develop and implement testing methods that are accurate to ensure quick release for time sensitive stock solutions. Identify critical testing points throughout the production process to minimize scrap lots and maximize disposition of finished goods.
• Contribute to the development and successful launch of our new products, devise test methods for new product evaluation, Coordinate and review out-sourced testing.
• Properly document results and assist in the development and improvement of laboratory SOPs. Update and maintain all laboratory databases with new results for record keeping and report generation.
• Lead Analytical equipment/system evaluation, upgrades and qualifications.
• Maintain calibration program for lab instruments
• Implement Continuous Improvements for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.
• Develop and maintain regular Quality Control trend data and provide periodic reports. Develop and maintain annual departmental budget plans.
• Develop and maintain quality performance metrics to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.
• Ensure staffing levels of exempt/non-exempt team members is balanced for the department and budget planned/balance accordingly.
• Ensure the quality of Incoming/In-Process materials to maximize the utilization of resources to meet budgetary goals. Ensure timeliness and efficiency of goods and material testing.
• Monitor and maintain departmental personnel to meet commitments/deadlines. Establish performance criteria, provide training and resources, give regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication.
• Make safety a priority consideration with all actions taken and ensure that safe work practices are followed and adhered to.

Education, Skills, & Experience:

• Bachelor's Degree is required, scientific or technical field is preferred.
• Requires a minimum of four (4) years progressively responsible experience in a chromatography (HPLC) with advanced knowledge of chemicals. Method development/validation (Chromatography method development and validation, method verification and method transfer is desired). Analytical Testing Technologies with an emphasis in HPLC testing, method verification and method validations, and inspection procedures.
• A minimum of three (3) years experience supervisory/manager experience is highly preferred. At a minimum, must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production.
• Proficient in Technical Writing, excellent verbal and written communication skills are a must as this position interacts at all levels of the organization.
• Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
• Must have a strong knowledge of GMP, ISO, and FDA compliance.