Analytical Laboratory Clerk, R&D
PharmaBiotechMedTechClinical ResearchRegulatory AffairsQuality Assuranceheoremafdainform
Job description
Analytical Laboratory Clerk, Research & Development About Site 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. Position Summary We have an opportunity for an Analytical Laboratory Clerk, Research & Development to join our team. This role is responsible for maintaining reference standard and column inventories, as well as managing the reference standard Certificate of Analysis database. The position ensures the laboratory remains audit ready, supports daily operations, and contributes to continuous improvement initiatives. The ideal candidate will help maintain a safe, clean, and collaborative work environment while supporting analytical and regulatory activities. Shift: Standard Hours, Monday through Friday Location: St. Petersburg, FL 100% Onsite The Role Maintain reference standard and column inventories, and manage the reference standard Certificate of Analysis database. Ensure the laboratory is in an audit ready state on a routine basis. Clean dissolution baths, water baths, sonicators, and wipe down bench tops. Gather supplies for analysts to execute daily work assignments. Perform daily cleaning of communal areas to ensure hygienic conditions for the next user. Keep general use equipment areas neat, clean, and organized. Assist with gathering data and making copies of reports and notebooks for customer and regulatory audits. Provide copies of notebook pages to auditors as needed for efficient auditing processes. Support continuous improvement initiatives and contribute to laboratory operational excellence. Maintain a safe work environment and collaborate with departments such as product development, quality control, safety, metrology, and quality assurance. Comply with Catalent, FDA, EPA, and OSHA regulations, performing all work safely. Perform other duties as assigned. The Candidate Minimum Requirements Requires a minimum of a high school diploma. General understanding of both chemical and biological hazards. Vision requirement: ability to read documents in English. 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. Ability to sit, stand, and walk regularly, and lift up to 25 pounds; no lifting greater than 44.09 pounds without assistance. Preferred Skills & Background Previous experience in a chemical, medical, or pharmaceutical setting or laboratory is a plus. Why You Should Join Catalent Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Competitive Paid Time Off plus 8 paid holidays. Medical, dental, and vision benefits effective day one of employment. Tuition Reimbursement – support to finish your degree or earn a new one. Employee Resource Groups focusing on Diversity and Inclusion. Environmentally friendly, community engagement green initiatives including regular participation in Beach Clean-up. Defined career path and annual performance review and feedback process with potential for career growth on an expanding team. WellHub program promoting overall physical and mental wellness. Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. 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 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 DisabilityAccommodations@catalent.com . This option is reserved for individua
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