Supervisor – Reagent Manufacturing PM shift

Supervisor – Reagent Manufacturing PM shift

Requirements

• Bachelor’s degree in scientific discipline with at least 8 years of experience in related field
• At least 4 years of experience in a high complexity and high-volume laboratory required
• Previous GMP laboratory experience required

Responsibilities

• Provide day-to-day supervision of personnel
• Oversee daily operations of the Reagent Manufacturing department including but not limited to scheduling, troubleshooting and resolving technical and non-technical issues
• Perform administrative duties including but not limited to writing employee performance evaluations, writing and reviewing SOPs, protocols, and equipment maintenance forms as assigned
• Perform NCR and CAPA investigations and address the discrepancies
• Coach and mentor Reagent Manufacturing Associates including but not limited to providing guidance, constructive feedback, and assistance with the development of skills
• Participate in introduction of reagent improvements, new reagent configurations and validations
• Participate in Regulatory inspection activities as needed
• Maintain sufficient inventory of material, supplies, and equipment in the laboratory for performance of duties
• Lead in the troubleshooting of manufactured reagents
• Lead in the revision and development of Reagent Manufacturing SOPs and forms
• Lead in interdepartmental activities with Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are always available for use
• Lead in the training of new and existing laboratory personnel on current and new procedures
• Oversee and document activities following GDP
• Lead team meetings
• Provide regular updates to management
• Effectively communicate technical information to technical and non-technical audiences
• Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and communicating these to the appropriate management representatives as necessary for resolution
• Perform equipment maintenance according to the laboratory’s standard operating procedures
• Perform other laboratory duties as assigned
• Ability to proactively communicate consistently, clearly, and honestly
• Strong computing skills
• Strong communication skills with the ability to maintain open communication with internal employees, managers and customers as needed
• Ability to integrate and apply feedback in a professional manner
• Ability to work as part of a team
• Perform biennial review of Standard Operating Procedures
• Report all concerns of test quality and/or safety to management, Laboratory Director, or Safety Officer

Preferred Qualifications

• Previous supervisory experience preferred
• Previous experience working on a PM shift preferred