Metrology Manager

Job Details

Job Location
ADMA Biologics FL - Boca Raton, FL

Description

ADMA Biologicsis a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic,innovative, growing company in thebiopharmaceutical industry that is committed toexcellence andintegrity, then consider ADMA Biologics. We have an exciting opportunity for a Metrology Manager.

The Metrology Manager is responsible for the management of the Instrument & Metrology Department and includes such activities as designing and writing departmental SOPs and planning and maintaining the ADMA calibration program, equipment, instruments, test standards, and recording databases. Procedures must be maintained to comply with NCSL standards and cGMP requirements. This position also maintains the accuracy and proper functioning of the control and monitoring systems on various equipment, and supports ADMA's plasma centers.

• Key Duties (ES): Direct, schedule and plan overall activities of the Instrument & Metrology department to ensure work is performed in an efficient and quality manner in compliance with company policies and SOP's, regulatory and EH&S standards, and cGMP practices.
• Create, implement and maintain operational procedures, including SOP's and other related documentation pertaining to the department.
• Create and maintain training standards and records to ensure staff and service vendors maintain required qualifications.
• Plan sequence of testing and calibration procedures for instruments and equipment and review calibration certificates and related documentation.
• Create and maintain equipment files for instruments and equipment including measuring and test equipment requiring calibration and the collection and filing of pertinent data and information related to routine and specific procedures and tests performed. Maintain and update the calibration system database using approved policies and procedures.
• Set up standard and specialized laboratory equipment to test, evaluate and calibrate other measuring and test equipment. Verify and approve data generated during calibrations. Disassemble measuring and test equipment to inspect components for defect. Align, repair and replace component parts and circuitry.
• Devise and use formulae to solve problems in measurement and calibration.
• Co-ordinate Metrology department activities based on information maintained and/or generated by the calibration database.
• Co-ordinate with equipment vendors for the maintenance and/or repair and external calibrations and procedures as needed and review certifications, service reports and data.
• Assist Engineering and Maintenance in the design, selection, and/or maintenance of instruments and equipment with respect to certification and calibration.
• Troubleshoot and replace all instrumentation in the manufacturing area. Complete all associated documentation including change controls, deviations and/or events in the quality system.
• Employee will be required to be on call and /or adjust work hours to accommodate production schedules. Overtime and weekend work may occasionally be required.
• Personal computer literacy, including familiarity with file management, Microsoft Word and Excel programs.
• Excellent organizational and communication skills are required to effectively communicate with non-technical and technical staff and all levels of personnel within and external to ADMA including regulatory inspectors.
• Supervisory Duties: Yes, Supervise Metrology Department personnel and external repair and/or calibration service vendors.

• Core Competencies/Behaviors: Able to work independently with minimal supervision. Experience with manufacturing measurement equipment, such as chart recorders, temperature controllers, pH and conductivity meters, incubators, autoclaves, multi-meters, pipettes, temperature and humidity transmitters using 4 to 20 milliamp current loops. Knowledge and experience working in a highly regulated environment using approved SOP's and procedures. Prior SAP experience required.
• Compliance Requirements (ES): As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.
• Physical Requirements (ES): While performing the duties of this job, the employee is required to stand, walk, sit and reach equipment by means of a ladder or mechanized lift. The employee may occasionally be required to lift and carry up to 50 pounds of delicate and sensitive calibration equipment. Exposure to human source products and to freezing temperatures for short periods of time. Specific vision abilities include close vision, depth perception and ability to adjust focus. May also be required to work evenings or weekends when production equipment is not in operation or to assist in the completion of projects and tasks.
• Stressors: Deadlines, emergency tasks and frequent interruptions

• Travel Requirements: N/A
• Physical Location of Role: Boca Raton, Florida

Qualifications

• Education Requirements: Bachelor's degree or a minimum of AAS degree or equivalent from two-year college program related to an electronics or electro-mechanical field.
• Experience Requirements: Minimum 10+ years experience supervising and/or performing calibrations in a CGMP regulated environment. Ability to read schematics and flow diagrams, troubleshoot circuits and hydraulic systems to the component level. Ability to create/review Standard Operating Procedures and interpret and follow equipment manuals, schematics, and drawings.
• Certification(s): N/A

• License(s): N/A