About BioCorp BioCorp is a leading dietary supplement manufacturer dedicated to producing high-quality nutritional products that meet the highest standards of quality, safety, and compliance. We partner with brands of all sizes to bring innovative supplement products to market through expert formulation, manufacturing, packaging, and regulatory support. At BioCorp, quality is at the core of everything we do. We are committed to maintaining strict cGMP standards, ensuring regulatory compliance, and delivering products our customers can trust. Our collaborative team is passionate about continuous improvement, operational excellence, and helping our clients build successful brands in the health and wellness industry. If you're detail-oriented, thrive in a fast-paced environment, and are passionate about producing accurate, compliant documentation that supports exceptional products, we'd love to have you join our team. Position Summary BioCorp is seeking a highly organized and detail-oriented Regulatory Documentation Specialist to support our growing operations team. This position is responsible for preparing accurate product quotations, creating manufacturing batch sheets, developing FDA-compliant Supplement Facts Panels (SFPs), and maintaining regulatory documentation for dietary supplement products. The ideal candidate has a strong understanding of dietary supplement manufacturing, FDA labeling requirements, and cGMP regulations. This role works closely with Sales, R&D, Quality Assurance, Production, Purchasing, and Project Management to ensure documentation is accurate, compliant, and production-ready. Compensation & Benefits Full-time, salaried position Competitive salary based on experience and qualifications Employer-sponsored health insurance available after the successful completion of the probationary period Paid time off and company holidays in accordance with company policy Opportunities for professional growth within a rapidly growing dietary supplement manufacturer Key Responsibilities Product Quotations Prepare accurate customer product quotations based on approved formulations, packaging specifications, manufacturing requirements, and customer requests. Coordinate with Sales, Purchasing, R&D, and Project Management to gather pricing and product information. Update quotations as formulas, packaging, or customer requirements change. Maintain organized records of quotations and revisions. Regulatory Documentation Create and maintain FDA-compliant Supplement Facts Panels (SFPs). Prepare manufacturing batch sheets for production. Verify formulas, serving sizes, ingredient declarations, and Daily Values for accuracy. Ensure all documentation complies with FDA regulations and internal quality standards. Maintain document revisions and version control. Label Compliance Review product labels for compliance with 21 CFR Part 101, 21 CFR Part 111, and DSHEA requirements.

Verify:

Supplement Facts formatting Ingredient statements Botanical nomenclature Allergen declarations Warning statements Net quantity statements Structure/function claims Coordinate revisions with Regulatory Affairs and Quality Assurance. Documentation Management Maintain controlled manufacturing and regulatory documentation within the company's document management system. Support document control procedures and company SOPs. Archive obsolete documentation according to established document retention policies. Ensure production teams receive the most current approved documentation. Cross-Functional Collaboration Work closely with R&D to ensure formulas are accurately translated into manufacturing documentation. Support Production with documentation updates and corrections. Assist Project Managers and Sales with documentation required for new product launches. Participate in documentation updates resulting from formulation, labeling, or regulatory changes. Qualifications Education Bachelor's degree in Food Science, Nutrition, Chemistry, Biology, Pharmaceutical Sciences, or a related field preferred. Associate degree with equivalent industry experience will also be considered. Experience Minimum of 2-5 years of experience in the dietary supplement, food, pharmaceutical, or nutraceutical ndustry.

Experience preparing:

Product quotations Manufacturing batch sheets Supplement Facts Panels Product labeling documentation Regulatory documentation Experience working in a cGMP manufacturing environment. Required Knowledge Candidates should have a strong working knowledge of:

FDA 21 CFR

Part 101 (Food & Dietary Supplement Labeling)

FDA 21 CFR

Part 111 (Dietary Supplement cGMP) Dietary Supplement Health and Education Act (DSHEA) Supplement Facts Panel requirements Daily Value calculations Ingredient declaration requirements Botanical nomenclature Proprietary blend formatting Document Control and Change Control procedures Good Documentation Practices (GDP) Technical Skills Advanced proficiency in Microsoft Excel and Microsoft Word Experience with ERP/MRP systems (Katana, NetSuite, SAP, Sage, or similar) Experience using document management systems (Dropbox) Strong mathematical aptitude and attention to detail Excellent proofreading and organizational skills Preferred Qualifications Experience with any of the following is a plus: NSF Certified for Sport® requirements Organic (NOP) certification Kosher and Halal documentation USP ingredient standards Third-party certification programs Quality Management Systems (QMS) Key Competencies The successful candidate will demonstrate: Exceptional attention to detail Strong organizational and time management skills Excellent written and verbal communication Ability to manage multiple projects and deadlines Strong analytical and problem-solving skills Ability to work independently and collaboratively across departments Commitment to quality, accuracy, and regulatory compliance Why Join BioCorp? At BioCorp, you'll be part of a team committed to producing high-quality dietary supplements while maintaining the highest standards of regulatory compliance and manufacturing excellence. You'll have the opportunity to work alongside experienced professionals in a collaborative environment where your attention to detail and technical expertise directly contribute to the success of our customers and products. If you're passionate about regulatory compliance, documentation accuracy, and supporting innovative health and wellness products, we'd love to hear from you.

Pay:

From $70,000.00 per year

Benefits:

Health insurance Paid time off

Education:

Bachelor's (Preferred) Ability to

Commute:

Melville, NY 11747 (Required)

Work Location:

In person