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Quality Assurance Chemist I

2 months ago


Cincinnati, Ohio, United States Chipton-Ross Full time
POSITION SUMMARY:

The Quality Control Scientist I is responsible for executing routine analyses and documentation of In-Process and Finished Product samples for pharmaceutical batch Release, Stability samples, or Projects within the QC Chemistry Laboratory, adhering to established standards.

This role supports internal development and manufacturing operations, making detailed observations and effectively communicating test results.


KEY RESPONSIBILITIES:
  • Conduct routine chemical testing of finished products and stability samples using both internally developed and compendial test methods.
  • Utilize validated test methods for pharmaceutical finished products to assess strength, impurities, identity, and characteristics through HPLC and wet chemistry techniques.
  • Identify and report out-of-specification or unexpected results and address non-routine analytical and product issues efficiently.
  • Perform daily instrument calibrations and verifications as required.
  • Document testing and analysis results accurately and clearly communicate findings.
  • Record and report analysis results in accordance with prescribed laboratory procedures and systems.
  • Prepare test solutions, including diluents and mobile phases.
  • Maintain a clean and organized work area and ensure proper maintenance of instrumentation.
  • Adhere strictly to Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
  • Maintain compliance with company and facility standards.

QUALIFICATIONS:
  • 1-2 years of experience in performing chemical tests with chromatographic techniques is preferred.
  • Strong theoretical knowledge of HPLC is required, along with practical execution skills.
  • Equivalent combinations of education, training, and relevant work experience may be considered.
  • Good understanding of basic instrumental technologies and qualitative and quantitative chemical analyses.
  • Awareness of quality and regulatory requirements in the pharmaceutical sector.
  • Strong problem-solving skills and a logical approach to scientific challenges.
  • Adhere to all company policies, SOPs, cGMPs, work instructions, methods, and analyst guidelines.
  • Demonstrate efficiency through multitasking and effective time management to meet workload demands.
  • Proactively seek additional assignments upon completion of primary responsibilities.
  • Show initiative in pursuing training and learning opportunities to enhance personal skills and share knowledge with team members.
  • Exhibit strong interpersonal and communication skills, both oral and written.
  • Ability to apply mathematical operations for tasks such as test reliability determination, variance analysis, and correlation techniques.
  • Capability to thrive in a fast-paced work environment.

PHYSICAL REQUIREMENTS:

This position requires ordinary ambulatory skills and physical coordination sufficient to navigate office environments. The role involves standing, walking, stooping, kneeling, and crouching for extended periods, as well as the ability to lift and carry light to medium weights (10-35 pounds). Manual dexterity is necessary for tasks such as typing and operating equipment, along with visual acuity for reading materials and using a computer.


SAFETY EQUIPMENT:
  • Safety glasses
  • Safety shoes
  • Lab coat
  • Latex or similar gloves
  • Safety apron
  • Organic respirator (as needed)

EDUCATION:

An accredited Bachelor's degree or higher in a physical science, preferably in Chemistry, is required.


WORK SCHEDULE:

This is a full-time position, Monday through Friday.