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Quality Control Chemist

2 months ago

Vandalia, Ohio, United States Adare Pharma Solutions Full time

Are you prepared to be part of a dynamic, international drug development and manufacturing organization that prioritizes its people? At Adare Pharma Solutions, we collaborate closely with our pharmaceutical partners throughout all stages of drug development, aiming to enhance the lives of patients and deliver essential medicines globally. Each position and department within Adare provides a unique, tailored experience, allowing you to make a significant impact that is vital to our success. With dedicated individuals like you, Adare is transforming lives by transforming drug delivery.


What can you expect from Adare?

  • Comprehensive medical, dental, vision, and life insurance with low employee premiums
  • 401k plan with a highly competitive matching contribution
  • Generous paid time off, including floating holidays
  • Opportunities for career advancement and internal mobility
  • Tuition reimbursement programs
  • Relocation support
  • Performance-based bonuses
  • Employee recognition initiatives

We are looking to fill the position of QC Chemist I - 3rd Shift within our Quality Control Team.


ROLE SUMMARY

The QC Chemist I plays a crucial role in the laboratory Quality team, responsible for conducting physical and chemical analyses of intermediate and finished products in accordance with established procedures.


KEY RESPONSIBILITIES AND LEARNING OPPORTUNITIES

  • Exhibit proficiency in various testing methodologies and analytical techniques, including sample preparation, titration, analytical balances, extractions, dilutions, chromatography, pH, and dissolution.
  • Prepare necessary standards, mobile phases, and buffers for diverse testing methods.
  • Conduct physical and chemical testing of raw materials, intermediates, and finished products as per documented procedures to support product release and process validation protocols. Propose method modifications as needed, with an understanding of USP methods.
  • Utilize basic laboratory equipment for testing, including rotating bottles, titrations, and dissolution baths.
  • Employ instruments such as UV, FTIR, GC, and HPLC for testing, demonstrating the ability to operate software applications, set up basic sequences, and report data accurately.
  • Perform swabbing and analysis of equipment cleaned by manufacturing with minimal supervision as required.
  • Conduct assigned calibrations for laboratory equipment and maintain compliance documentation.
  • Identify and report Out of Specification results, Out of Trend results, and deviations to the Supervisor, assisting with investigation steps for LIR/OOS Investigations as necessary.
  • Maintain accurate notebooks and files in compliance with current GMPs and internal Standard Operating Procedures, reviewing or auditing others' work for GMP compliance.
  • Demonstrate a consistent ability to perform testing with minimal need for re-investigation.
  • Report test data accurately in various formats.
  • Ensure laboratory equipment and work areas are kept in good condition.
  • Adhere to all safety procedures and regulations.
  • Assist in training temporary personnel.

QUALIFICATIONS

  • Bachelor's Degree in Chemistry or a related field.
  • Minimum of 1 year of experience in a Quality Control or Research and Development Laboratory, preferably within the pharmaceutical sector.
  • Strong interpersonal, written, and verbal communication skills.
  • Familiarity with current Good Manufacturing Practices (GMPs).
  • Proficient in Microsoft Excel and Word; experience with Microsoft Access is a plus.
  • Basic technical writing skills combined with effective oral communication abilities.

PHYSICAL REQUIREMENTS

  • Ability to stand, walk, push, pull, twist, reach overhead, and bend down.
  • Occasional climbing of ladders or steps to access equipment.
  • Capable of reading precision measuring instruments, machine dials, gauges, and thermometers; must be able to observe fine details using a microscope.
  • Must possess a sense of smell to detect odors of unacceptable compounds or mixtures.
  • Good physical coordination and steady hands are required to handle delicate laboratory instruments and equipment.
  • Personal protective equipment (PPE) may be required during certain operations, including high noise areas, exposure to various chemicals, or dust, mists, and fumes.
  • Training in Hazardous Communication Standards and the use of mandatory PPE is provided for employees exposed to these conditions.
  • Engineering controls are implemented to minimize or eliminate exposure to hazardous conditions wherever feasible.

BENEFITS

  • Comprehensive medical, dental, vision, and life insurance with low employee premiums.
  • 401k plan with a highly competitive matching contribution.
  • Generous paid time off, including floating holidays.
  • Opportunities for career advancement and internal mobility.
  • Tuition reimbursement programs.
  • Relocation support.
  • Performance-based bonuses.
  • Employee recognition initiatives.

Adare Pharma Solutions is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, and veteran status.