With over 18 years in the nutraceutical industry, White Bottle has a strong passion for developing the best nutritional supplements, vitamins, and herbal products that nature can offer. Our approach to private label manufacturing is customer-centric, anticipating your needs and your customers’ taste. We believe that transparency is the only way to create working partnerships with our clients. We want our customers to know every detail of our formula development as well as get the advice they need to feel totally confident with the quality of their products. Every client is unique and deserves special attention no matter the size. We focus on providing the best user experience by ensuring that our products will ultimately serve your practice.
Job Summary
We are seeking a detail-oriented and highly organized R&D Documentation Specialist to support our Research & Development team by managing technical documentation throughout the product development lifecycle. This role ensures documentation complies with internal standards and external regulatory requirements, enabling efficient collaboration and audit readiness.
Key Responsibilities and Duties
- Oversee the document lifecycle, including creation, review, approval, distribution, and archival of R&D documents, such as specifications, formulas, test methods, and batch records.
- Input specifications into Genesis software program for SFP creation.
- Implement and enforce a version control system to track document revisions and ensure that the most current and approved documents are in use across the organization.
- Ensure all documentation practices and records adhere to relevant industry standards and regulations, such as Good Manufacturing Practices (GMP), FDA 21 CFR Part 11, or ISO standards, depending on the industry.
- Coordinate the flow of documents through the review and approval process, working with subject matter experts to ensure technical accuracy and completeness.
- Manage both physical and electronic records, ensuring secure storage and efficient retrieval of documents for audits, inspections, and internal requests.
- Maintain and troubleshoot the electronic document management system (EDMS), ensuring all documents are properly categorized and stored.
- Prepare documentation packages to support internal and external audits or regulatory inspections and assist in the resolution of any audit findings.
- Provide training to R&D staff and other departments on document control procedures and best practices for documentation.
- Identify and recommend opportunities to improve document control processes, procedures, and system usage to increase efficiency and accuracy.
Qualifications
- Education: Bachelor's or Associate's degree in a relevant field such as Food Science, Chemistry, Engineering Or equivalent work experience.
- Experience: 2+ years of experience in document management or document control, preferably in a regulated R&D environment (e.g., medical device, pharmaceutical, or nutraceutical).
- Exceptional organizational skills and meticulous attention to detail to ensure the accuracy and integrity of all documents.
- Strong computer skills, including expertise in Microsoft Office Suite (Word, Excel) and experience with ERP systems.
- Excellent written and verbal communication skills to effectively collaborate with cross-functional teams and create clear and concise documentation.
- Familiarity with industry-specific quality standards and regulatory requirements (e.g., FDA, GMP).
- Strong analytical and problem-solving skills to manage multiple priorities and resolve documentation issues.
- Ability to work both independently and collaboratively in a team environment.
Work Environment
- This role is primarily office-based with prolonged periods of sitting at a desk and working on a computer.
- This position includes occasional visits to the production floor. Requires frequent standing and walking between production buildings as needed. Must be able to access and navigate each department at the organization's facilities.
- Must be able to safely walk up and down stairs without assistance.
- Must be able to safely lift up to 20 lbs unaided and perform tasks that require bending, crouching, and lifting throughout the shift.
- Frequently exposed to varying extreme conditions and loud noise levels.
- Regular use of standard office equipment, including computers, phones, photocopiers, filing cabinets, and fax machines.
- Personal Protective Equipment (PPE) is required for various environments.
Pay: $18.00 - $25.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Education:
Experience:
- Document management: 2 years (Preferred)
- Research & development: 2 years (Preferred)
Ability to Commute:
- Stanton, CA 90680 (Required)
Work Location: In person
