Analytical Services Manager
- Employer
- Formulated Solutions
- Location
- Largo,FL
- Salary
- Open
- Posted
- May 06, 2017
- Closes
- Jun 02, 2017
- Ref
- 2823833233#FL--J2CBackfill.1
- Industry
- Professional
- Category
- Operations
PRIMARY PURPOSE: Assign, direct and manage analytical laboratory operations. Ensure continuity in laboratory abilities in HPLC, Gas Chromatography and AA. Must have extensive cGMP experience and be able to provide leadership and mentoring to lab personnel. Must have thorough understanding of Good Laboratory Practices, Good Documentation Practices and Analytical Method Validation. Must have proven experience in Analytical Method Validation including developing methods, preparing protocols, interpreting data and writing summary reports. Must have experience in writing Standard Operating Procedures. MAJOR DUTIES AND RESPONSIBILITIES: Prioritize and coordinate analytical and physical testing activities to meet timeline and budgetary commitments. Testing includes incoming raw materials, in-process samples, finished product samples and stability samples. Ensure testing is performed accurately and in compliance with cGLP, cGMP, USP, EP, SOP and other approved test methods. Review data and reports ensuring precise and accurate testing is performed. Manage the development, implementation and training of new validated quantitative methods for the laboratory. Manage the stability program. Train laboratory personnel in the use of equipment and analytical techniques. Responsible for out of specification test results, investigation and implementation of corrective actions. Solve complex analytical problems. Assist Validation teams in process validation activities. Interpret Master Manufacturing Formula documents and support transfer of new products. Ensure adherence to OSHA guidelines with regards to work practices and safety. Qualification, calibration and maintenance of all laboratory equipment. Write, review and revise SOP s and Test Methods as required. Review and revise laboratory systems on an ongoing basis. General laboratory maintenance. Coordinating and reviewing OEM instrumentation preventive maintenance. Other duties which may be assigned by the Director of QualityQUALIFICATIONS: Required Knowledge of compendia (i.e. USP, EP, BP, JP, etc) testing. Working knowledge of FDA regulation for drug/device especially for the analytical lab. Ability to use a personal computer and peripheral equipment to accurately enter an analyze data and produce reports. Knowledge of chemical safety and protective equipment. Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectrum, HPLC, UPLC, GC, atomic absorption. Ability to establish priorities, work independently, productively, and proceed with objectives without supervision. Ability to handle and resolve recurring problems. Communicate with others clearly and concisely. Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work. Must be able to lift up to 15 pounds. EDUCATION AND TRAINING: Minimum Bachelor s degree in Chemistry or appropriate discipline. Must have a minimum of 8 years experience and previous supervisory experience in an analytical laboratory in an FDA regulated