Associate Scientist II, Quality Control

Catalent Pharma Solutions•St. Petersburg, FL
•Onsite

About The Position

The Associate Scientist II - Quality Control performs analysis of finished products, in-process materials, raw materials, and validation samples using established specifications, methods, protocols, and compendial monographs. The role also includes microbiological identification, reagent and media preparation, and maintaining complete and accurate records in compliance with Good Manufacturing Practices and applicable procedures. The position requires attention to detail, adherence to safety standards, and the ability to work under moderate supervision in a dynamic laboratory environment. This is a salaried position at Catalent’s St. Petersburg, Florida facility. The stated schedule is Tuesday through Saturday, 8 a.m. to 5 p.m.; shifts may support manufacturing on weekends and holidays, and hours may change based on departmental needs. The position is 100% onsite.

Requirements

  • Bachelor’s degree required.
  • Ability to work effectively under pressure to meet deadlines.
  • Ability to sit, stand, and walk regularly, and occasionally lift up to 15 pounds; lifting more than 44.09 pounds requires assistance.
  • Ability to differentiate color by passing the Ishihara Color Vision Screening and achieve 20/30 far and near visual acuity in both eyes, with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is identifying at least 4 of 6 numbers in the circles.
  • Ability to be accessible to manufacturing, laboratory, and office staff.
  • Ability to use required office equipment.

Nice To Haves

  • Experience or skills with UV spectroscopy, IR and AA instrumentation, HPLC and GC instrumentation, autoclave and Vitek systems, or dissolution testing.
  • Knowledge of wet chemistry techniques such as titrations, extractions, digestions, and preparation of test solutions.
  • Knowledge of safety and hazardous waste requirements, data acquisition applications and databases, and conducting and writing laboratory investigations.

Responsibilities

  • Analyze finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to assigned specifications, methods, and protocols.
  • Perform analysis of finished products and validation samples, as well as moisture, gas, water, and environmental sampling and testing, following applicable specifications, protocols, and compendial monographs.
  • Cultivate and identify microorganisms on selective and non-selective media, and maintain cultures according to ATCC and departmental Standard Operating Procedures.
  • Identify microorganisms using techniques such as API and Gram stain.
  • Prepare reagents, standards, and media needed for analysis.
  • Work with potent and teratogenic compounds as required.
  • Log samples into the GLIMS database and logbooks; interpret and record results in approved notebooks, reports, and logbooks.
  • Perform basic statistical analysis to support testing and verify calculations and results for accuracy and integrity.
  • Assist with receiving, labeling, and storing solvents and reagents; maintain inventory of glassware, chemicals, and materials.
  • Calibrate analytical equipment, including balances, pH meters, and KF analyzers; maintain and clean laboratory instruments and equipment.
  • Dispose of hazardous waste according to regulations and procedures.
  • File and maintain laboratory records in accordance with Good Manufacturing Practices and applicable SOPs.
  • Assist in writing, reviewing, or revising procedures and laboratory investigations.
  • Perform other laboratory-related duties as required, including cleaning glassware.
  • Work shifts in support of manufacturing, including weekends and holidays; hours may change based on departmental needs.

Benefits

  • Competitive paid time off and 8 paid holidays.
  • Medical, dental, and vision benefits effective on the first day of employment.
  • Tuition reimbursement.
  • Employee Resource Groups focused on diversity and inclusion.
  • Defined career path with annual performance reviews and potential for growth within an expanding team.
  • WellHub program promoting physical and mental wellness.
  • Perkspot discounts from more than 900 merchants.
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