Batch Records & Formulation Specialist (Pharmaceuticals / Nutraceuticals)

Batch Records & Formulation Specialist (Pharmaceuticals / Nutraceuticals) Nutraceuticals Inc. Miami, FL Job Details Full-time 4 hours ago Qualifications Teamwork Document review (document control) Pharmaceutical regulatory compliance ERP systems Continuous improvement Attention to detail Batch records Quality standards in production FDA regulations Full Job Description Summary The Batch Records & Formulation Specialist is a dual-function role responsible for creating and reviewing batch production records while also supporting product formulation and process development . This position ensures manufacturing documentation is accurate, compliant, and audit-ready, while contributing to formula updates, ingredient specifications, and scale-up activities for nutraceutical products. Key Responsibilities Batch Records & Documentation Create, revise, and issue Master Batch Records (MBRs) and Batch Production Records (BPRs). Review completed batch records for accuracy, completeness, and cGMP compliance. Verify material usage, yields, and lot traceability. Coordinate corrections, deviations, and documentation updates with QA and Production. Maintain controlled documents in accordance with 21 CFR Part 111 and internal SOPs. Formulation & R D Support Assist in developing and modifying formulas for capsules, tablets and powders,. Prepare formulation worksheets, ingredient specifications, and manufacturing instructions. Support scale-up from R D to production, documenting critical process parameters. Evaluate ingredient functionality, stability considerations, and processing behavior. Collaborate with QA to ensure formulation changes align with regulatory and quality requirements. Cross-Functional Collaboration Work closely with Production, QA, QC, and Supply Chain to ensure accurate documentation and smooth batch execution. Support audits by preparing documentation and responding to technical questions. Assist in implementing or maintaining EBR/ERP systems (e.g., Mar-Kov, MRPeasy, BatchMaster). Qualifications Required 2-5 years of experience in Nutraceutical, Pharmaceutical, Food, or related manufacturing. Strong understanding of cGMP and 21 CFR Part 111 documentation requirements. Experience preparing or reviewing batch records. Basic formulation or R D experience (ingredient functionality, formula adjustments, process steps). Preferred Experience with multiple dosage forms (capsules, tablets, powders, liquids, gummies). Familiarity with EBR/ERP systems. Knowledge of blending, granulation, encapsulation, tableting, or liquid processing equipment. Strong analytical and documentation skills. Competencies High attention to detail and accuracy. Strong communication and cross-functional teamwork. Ability to interpret formulas, technical data, and manufacturing processes. Problem-solving mindset with a focus on compliance and continuous improvement.

Experience:

Formulation of pharmaceuticals / nutraceuticals: 2 years (Preferred) Batch records creation and management: 2 years (Preferred)

Language:

Spanish (Preferred)

Work Location:

In person