Responsible for creation and/or acquisition, tracking and maintenance of R&D technical documents related to formulations, raw materials, and other department projects. This position communicates directly with internal and external partners related to formula, raw material and other technical document and project-related tasks. Responsible for ongoing maintenance of R&D document files and preparation, review and routing of regulatory-related and technical documentation in support of product development process.
Essential Duties & Responsibilities
Assist with/Prepare, review, update, track and maintain records of all technical documents and relevant development projects (in collaboration with R&D formulation team and/or cross-functional team members), including but not limited to:
Formula Genesis reports
Label copies
Raw material specifications
Product specifications
Product justifications
Master batch records
Testing requests
Testing results
Material transfer requests
Document change requests
Technical reports
Assist in ensuring formula/raw material related documentation is routed to appropriate cross-functional team members in correspondence with processes
Organize and maintain raw material and product certifications for customers
Request, evaluate, update and maintain required certification documents for raw materials and/or formulas
Organize certification files for periodic audit by external certifying bodies
Liaise with external certifying body representatives for review of certification documentation
Support, organize and track qualification of new, existing and replacement raw materials and alternate suppliers as assigned
Request, receive, review and evaluate, track, and maintain raw material documentation for customer formulas and R&D projects
Liaise with raw material supplier representatives for raw material documentation and/or information
Organize and track requests/receipt of raw material documents for R&D benchtops, pilot and production.
Review raw material documentation for accuracy and R&D requirements
Collaborate with R&D formulation team on raw material document updates or identified issues
Maintain raw material documentation files for updates
Assist in sending and receiving compliance documents from raw material suppliers
Assist in preparation of regulatory and technical documents
Request, receive, and track raw material sample requests for R&D benchtop and pilot trials
Ensure R&D pilot lab has required materials for benchtop and pilot trials
Collaborate with R&D formulation team to request, organize and track raw material samples and in-house materials for benchtop and pilot trials
Submit raw material samples for testing/evaluation and track status and results
Collaborate with R&D formulation team and/or raw material supplier representatives on out of spec testing results
Label and track raw material samples for clinical trials
Build strategic relationships and maintain effective and professional communication with raw material suppliers in collaboration with Purchasing team
Support Purchasing team in sourcing raw materials and obtaining necessary documentation to support evaluation of raw materials
Provide on-going internal and external technical support to ensure benchtop, pilot and production needs are met and customer requests are satisfied.
Assist in coordination of special projects as needed, such as but not limited to clinical studies, International Product Development and Registration documentation
Lead conducted stability protocols for customers
Collaborate with R&D formulation team in creation of stability protocols
Implement and track activities related to stability protocols
Monitor product samples and submit for lab analysis
Gather, evaluate and summarize stability test results
Collaborate with R&D formulation team in review of stability data
Maintain R&D stability chambers
Collect, track and maintain customer stability data not conducted at
Other Duties
Maintain awareness of current developments within the functional discipline
Develop a network of raw material and technical support contacts within the industry
Collaborate with and support entire R&D department and cross-functional teams
Take leading role for projects as assigned.
Perform other related duties as assigned
Qualifications
Requires a four year college or university degree or its equivalent in Pharmacy, Chemistry, Food Science, Chemical Engineering, or related field
Requires a minimum of two years industry R&D or Quality experience, ideally with two years of related experience. Some knowledge of industry regulations - US or international a plus.
Possess knowledge and practical experience with nutraceutical or food ingredients and documentation, reviewing and summarizing analytical data, and a firm foundation in chemistry, mathematics, pharmaceutics and/or food science
Proficient in oral and written communication skills as well as effective organizational skills and the ability to make presentations and recommendations in the area of responsibility
Must be able to communicate effectively and professionally in a cross functional team environment and with external customers
Must have computer literacy, including word processing and spreadsheet software
Must have sound judgment and decision-making skills
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or
