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Associate Scientist II, Quality Control

Position Summary

+ **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.

The Role

+ 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.

The Candidate

+ 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.

Why You Should Join Catalent

+ Competitive medical benefits and 401K

+ 152 hours of PTO + 8 Paid Holidays

+ Dynamic, fast-paced work environment

+ Opportunity to work on Continuous Improvement Processes

**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .