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The Pure Source

Quality Control Batcher

The Pure Source, Doral, Florida, United States

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Overview

The R&D Formulator is responsible for all aspects of product formulation, product/process development, scale up and commercialization of creams, lotions, ointments, and liquids in at a high-paced Contract Manufacturer. This role explores and conducts research in relevant technologies for product innovation and product/processes enhancement for Cosmetics and OTC products.

Responsibilities:

· Research and develop new Cosmetics, Pet, and OTC products according to customer demand and market trends

· Support new products formulation through lab batching, raw material procurements, sample submissions, and lab stability monitoring

· In charge of converting lab batch processes designed by formulator technicians into a technology transfer/GMP compliant processes.

· Establish required product and manufacturability specifications for feasibility and scalability

· Continuously improve existing products including formula modifications, raw materials substitutions and manufacturing instruction improvements to fulfill sales & marketing strategies

· Generate master formulas by inputting approved formulas into ERP system and establishing formulas’ BOM, manufacturing procedures, sampling plans, product specifications and instructions for drumming off, storage and filling

· Review and evaluate formulas and compounding procedures

· Troubleshoot manufacturing issues, identified root causes and provided resolutions and corrective and preventive actions (CAPA); lead all production batch adjustment

· Conduct change control request (CCR) for any modifications for master formulas and inform the changes to associated departments including R&D, Quality, Purchasing and Planning to ensure the integrity and consistency of product quality

· Source and test new ingredients to meet marketing and regulatory demands, sourced and qualified alternative ingredients to the current ones with supply issues

· Provide recommendations to Production / Compounding Manager on feasibility of use of raw materials and/or make suggestions for possible changes

· Provide support in preparation of batch records, process characterization reports, verification reports, corrective actions (CAPA) and investigation reports.

· Evaluate raw material for formulation assessment to ensure compliance to regulatory requirements.

· Interaction with raw material manufacturers and other vendors as needed.

· Prepare appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.

· Additional duties as assigned

Qualifications:

· Bachelors degree in Chemistry, Pharmaceutical Science, or related science with minimum of 4 years of relevant experience in product development in cosmetics or pharmaceutical industries

· Masters degree in Pharmaceutical Science preferred

· Must have experience formulating cosmetic, SPF, dietary supplements, or topical OTC products

· Excellent written and verbal communication and interpersonal skills with the ability to communicate effectively with multiple levels within the organization

· Project management skills to handle multiple projects at a time

· Comprehensive knowledge and practical experience with product/process development, processing laboratory techniques and regulatory requirements and a foundation in chemistry, mathematics, and or pharmaceutics.

· Strong critical thinking and problem-solving skills.

· Must comply with GMP requirements; specific functions and documents will be discussed in GMP and on the job training.