Associate Scientist II, Quality Control

Catalent•Saint Petersburg, FL

2d•Onsite

About The Position

Work Schedule: Monday through Friday, Standard Hours 100% on-site Join Catalent’s flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. The Associate Scientist II, Quality Control role is responsible for independently performing testing and developing assays to identify and characterize raw materials, in-process samples, stability samples, and finished products. The position involves analyzing and documenting data in compliance with cGMP and internal guidelines, communicating results, and supporting procedures, specifications, and test method development. This role is fully on-site in St. Petersburg and includes training colleagues, continuous improvement efforts, and strict adherence to FDA, EPA, OSHA, and safety requirements.

Requirements

Requires BS or BA with college course work in related sciences.
Analytical laboratory experience preferred but not required.
Experience with common pharmaceutical laboratory equipment including but not limited to: experience with U.V. spectroscopy experience with IR and AA instrumentation, H.P.L.C. and G.C. instrumentation experience, Autoclave, Vitek, and dissolution testing.
Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.
Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.

Responsibilities

Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective Specifications, protocols, Methods and Compendial monograms.
Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.
Maintains cultures according to ATCC and departmental Standard Operating Procedures.
Performs identification of microorganisms using techniques such as API, Gram Stain, etc.
Prepares reagents, standards, Medias, etc. needed for analysis.
Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks.
Other duties as assigned.