Company Name: Actavis, Inc. Import
Job Details
Duration: Permanent
Min Education: Not Specified
Salary: Commensurate
Job Type: Full Time
Min Experience: Not Specified
Required Travel:
  • USA - Ft. Lauderdale Florida, 33301
Job Description

Summary: Essential Job Functions: Under minimal supervision, conducts method investigations, method validations, method transfers, and method comparisons. Initiates Laboratory Technical Services (LTS) projects and assists in experimental design, internet and library research, and critically analyzes data in support of project directives. This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. * Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. * Prepares method development, method validation, analytical strategy reports and other relevant scientific information packages for internal and external use by the Company. * Writes, reviews and executes protocols and reports for method investigation/method validation independently. Investigations may be complex and validations may require advanced technical and analytical problem solving skills. * Performs method development projects working with senior colleagues for direction/consultation. * Serves as a LTS department representative for all site projects/initiatives. Provides scientific and technical support to laboratory personnel. * Trains personnel on analytical instrumentation, techniques, and projects. * Provides support for laboratory investigations, conducts validation studies, and assists in writing project plans and experimental designs. * Reviews and reports on compendial FDA guidelines revisions. Develops department strategy. * Designs databases and spreadsheets; utilizes statistical and laboratory/data applications to solve analytical problems and display data/results. * Carries out cGMP and technical training, as it pertains to area of work. * Performs advanced instrument troubleshooting. * Provides support and coaching to subordinate employees in the areas of training, planning, and work assignment. * May develop, write and review new procedures, test methods and specifications documents. May also update existing procedures, test methods and specifications documents. * Ensures project deadlines and performance standards are established and met. * Ensures compliance with all Company policies and procedures, including safety rules and regulations. * Performs related duties as assigned.Qualifications

Knowledge of: * Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. * UV/IR, HPLC, AA and GC instruments, dissolution testing, operation methods and techniques. * FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines. * Spectroscopic and chromatographic operation, techniques and systems. * Advanced Chemistry, pharmaceutical and statistical theories, methods and procedures. * Business, scientific, and personal computer hardware and software applications. * Business English usage, spelling, grammar and punctuation. * Supervision, leadership and training practices and methods. * Current Company policies, practices and procedures, including safety rules and regulations. Skill in: * Responding to inquiries from management, employees and regulatory agencies. * Working with high degree of independence and of conceiving and achieving technical goals with little or no technical supervision. Training of junior staff. * Leading the activities of technical personnel; making decisions and satisfying the needs of a research program. * Communicating clearly and concisely, both orally and in writing. * Operating scientific and personal computers. * Managing multiple projects, duties and assignments. * Coordinating and reviewing the work of assigned department personnel. * Technical report writing. * Establishing and maintaining cooperative working relationships with others. * Ensuring compliance with all Company policies and procedures, including safety rules and regulations. Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and occasional business travel. Work is performed in an office environment.Education

Minimum Qualifications: Bachelor's Degree in Chemistry or related science field from an accredited college or university with nine (9) to thirteen (13) years related experience; or an equivalent combination of education and experience. Knowledge of FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines. Graduate degree preferred. Pharmaceutical experience a plus.