Quality Assurance Specialist

1 month ago

Danbury, Connecticut, United States Vantage Point Recruiters, LLC. Full time
Job Title: Quality Control Chemist

Join our team at Vantage Point Recruiters, LLC. as a Quality Control Chemist and contribute to the success of our company.

About the Role:

We are seeking a highly skilled Quality Control Chemist to join our team. As a Quality Control Chemist, you will be responsible for ensuring the quality of our products by conducting routine and non-routine analysis of raw materials, in-process, and finished formulations according to standard operating procedures.

Key Responsibilities:
  • 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.
  • 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.
  • Participate in the preparation of investigations, summaries and reports.
  • Review data obtained for compliance to specifications, report abnormalities and may lead root cause investigations.
  • Write, revise and update standard operating procedures as needed.
  • Apply knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
  • 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.
  • 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.
Requirements:
  • 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.
  • Must have knowledge of Empower Software
  • 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 Good analytical chemistry and quantitative and qualitative analytical skills.
Skills and Certifications:

Empower // HPLC // Raw Materials // Finished Products // Pharmaceutical Experience

We are looking for a highly skilled Quality Control Chemist to join our team. If you have a strong background in analytical chemistry and experience in HPLC analysis, we encourage you to apply.

Bill Marek - CEO

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