Associate Scientist II, Quality Control

Catalent Pharma Solutions•St. Petersburg, FL

12d•Onsite

About The Position

Associate Scientist II, Quality Control Position Summary Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Associate Scientist II, Quality Control will independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. In addition, this role will Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines, communicate results in written and oral presentations, help in writing Procedures, Specifications and Test Methods. The Associate Scientist II, Quality Control will keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group, comply with FDA, EPA and OSHA regulations, performing all work in a safe manner and maintain proper records in accordance with all SOP's and policies. This position is 100% on-site at the St. Petersburg site.

Requirements

Requires BS or BA with college course work in related sciences, analytical laboratory experience preferred but not required.
Must possess good interpersonal skills.
Ability to effectively communicate with co-workers.
Good organizational skills 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.
Knowledge of safety and hazardous waste requirements
Knowledge of data acquisition applications and databases
Experience in conducting and writing laboratory investigations
Ability to work effectively under pressure to meet deadlines.
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.