Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes chemical, biological or microbiological products, raw materials, in process materials, or stability samples in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Essential Duties
Conduct routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures.
Act independently to determine methods and procedures on new assignments.
Perform experiments in accordance with written procedures and/or under the direction of a supervisor.
Manage equipment calibrations/qualifications with minimal supervision.
Assist in the development and training of peers and less skilled employees in the execution of analyses and/or the use of specialized equipment.
Perform microbiological and/or chemical analyses of product to ensure stability.
Compile data for documentation of test procedures that may include microbiological and chemical assays, stability program testing and formulation studies.
Calibrate and maintain lab equipment.
Participate in the preparation of investigations, summaries and reports.
May lead in developing test methods.
Review data obtained for compliance to specifications, report abnormalities and may lead root cause investigations.
Write, revise and update standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
Apply knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
Follow written test methods and protocols.
Summarize and/or process data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data.
Demonstrate good understanding, with a working knowledge, and ability in primary scientific discipline. Trouble shoot a wide selection of instruments (e.g. balances, FTIR, HPLC, GC, Delivered dose, cascade impactors, environmental monitoring equipment, Vitek) or is a specialist in a scientific field such as metrology or technical documentation.
Summarize and/or process data and prepare tables and graphs for submission to regulatory agencies.
Ability to recognize issues and develop strategy to proceed forward with supervisor's input.
May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
Represent the group at appropriate meetings.
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
BS Degree in Chemistry with 4-6 years or MS Degree with 2-4 years or PhD Degree with 0-2 years related experience.
A working understanding of /experience in GMPs and regulatory guidance.
Ability to think analytically along with good communication, organizational and interpersonal skills.
Must have knowledge of Empower.
Must have experience in HPLC analysis and other required analytical techniques.
Proficient in the use of a word-processing and spreadsheet program.
Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred.
Good analytical chemistry and quantitative and qualitative analytical skills.
An understanding of the basic statistical concepts and working knowledge of one or more statistical and other technical software packages.
Excel, Word and Power Point skills.
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