Associate Scientist II, Quality Control

• 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, validation samples, moisture testing, gas, water, and environmental sampling and testing following effective specifications, protocols, and compendial monographs.
• Cultivate and identify microorganisms on selective and non-selective media; maintain cultures per 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 GLIMS database and logbooks; interpret and record results in approved notebooks, reports, and logbooks.
• Perform basic statistical analysis to support testing; 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 such as balances, pH meters, and KF analyzers; maintain and clean laboratory instruments and equipment.
• Other duties as assigned.

St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.