Company Overview
MacroCap Labs Inc is a dynamic manufacturer and parent company of well-known national brands serving diverse consumer segments. With a vertically integrated approach from production to retail, MacroCap Labs ensures comprehensive coverage across a broad network of domestic and international retailers, including major outlets in the sports nutrition and food sectors.
Overview
We are seeking a highly organized and detail-oriented Specifications & Document Control Specialist to join our team. This pivotal role involves managing and maintaining all technical and quality documentation to ensure compliance with industry standards and regulatory requirements. The ideal candidate will thrive in a fast-paced environment, demonstrating technical proficiency, excellent communication skills, and a passion for quality management. This position offers an exciting opportunity to contribute to the integrity of our product development and manufacturing processes.
Responsibilities:
1. Create, format, and maintain product specifications for finished beverages, supplements, raw materials, and packaging.
2. Develop and control R&D documentation including formulas, batch records, specification sheets, and technical data sheets in accordance with document control procedures.
3. Maintain the document control system, including version control, revision history, document numbering, and controlled distribution of current documents.
4. Review specifications and supporting documents for accuracy, completeness, and consistency with formulation and regulatory requirements.
5. Compile and organize technical documentation to support customer requests, new product launches, and regulatory submissions.
6. Coordinate document review and approval workflows, routing documents to the appropriate personnel and tracking approvals to completion.
Archive obsolete documents and ensure only current, approved versions are available for use.
Requirements
- Proven experience in document control within the engineering or manufacturing industry, preferably in regulated environments such as pharmaceuticals or medical devices.
- Strong knowledge of ISO 13485 (medical device quality management system), ISO 9001 (quality management systems), FDA regulations, and pharmaceutical regulatory compliance standards.
- Proficiency with SharePoint or similar document management systems for workflow management and version control.
- Excellent organizational skills with the ability to manage multiple documents simultaneously while maintaining accuracy.
- Technical proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) for document creation and data management.
- Experience with project management software is a plus for tracking document lifecycle activities.
- Strong attention to detail for proofreading, data management, and ensuring document compliance.
- Effective cross-functional communication skills to coordinate with various departments on document review and approval processes.
Job Knowledge, Skills, and Abilities:
- Ability to communicate with others clearly and concisely both verbally and in writing.
- Ability to read and comprehend technical literature, written instructions, specifications, and formulation records.
- High level of attention to detail and accuracy in document preparation and data entry.
- Proficiency with document control practices, spreadsheets, and word processing software.
- Math skills required: add, subtract, multiply, divide, percent, conversions, rounding.
Qualifications:
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Ability to perform error-free work.
- Able to organize and provide written and/or oral presentations of work with minimal input from others.
- Demonstrate the ability to function independently and productively in support of new and existing customer projects.
- Strong organizational skills with the ability to manage multiple documents and revisions simultaneously.
- Operates with a sense of urgency and consistently demonstrates the ability to prioritize workload.
Requires close vision (clear vision at 20 inches or less), clear vision (clear vision at 20 feet or more), and color vision (ability to identify and distinguish colors); peripheral vision, depth perception and ability to adjust focus.
Education and Experience:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- One (1) to three (3) years related experience in document control, technical writing, specification development, or quality/regulatory documentation.
- Experience maintaining controlled documents and revision-controlled record systems.
- Familiarity with FDA regulations including Good Manufacturing Practices (GMP) and dietary supplement and food labeling requirements.
Beneficial Experience:
- Previous experience in food and beverage or dietary supplement manufacturing, quality control, regulatory compliance, or Global Food Safety Initiative (GFSI) benchmark schemes including SQF.
Join us as a Specifications & Document Control Specialist to play a vital role in upholding our commitment to quality excellence! Your expertise will help ensure our products meet the highest standards of safety and compliance while supporting our innovative growth in the industry.
Benefits:
- Competitive salary
- Health, dental, and vision insurance
- Retirement plan options
- Paid time off
Equal Employment Opportunity Statement:
Macro Cap Labs, Inc. is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable federal, state, or local laws.
We believe in fostering a workplace where everyone feels respected, valued, and able to contribute to their full potential.
Pay: From $46,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- AD&D insurance
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Application Question(s):
- How many years of experience do you have working in a food, beverage, dietary supplement, pharmaceutical, or other regulated manufacturing environment?
- Have you created or maintained controlled documentation in accordance with GMP or ISO quality systems?
- Which document management systems have you used (e.g., Master Control, Veeva, SharePoint, Qualio, ETQ, or similar)?
- Describe your experience creating and maintaining technical documentation such as product specifications, formulas, batch records, or specification sheets. What types of products have you supported?
- What document control systems or software have you used to manage version control, revision history, and document approvals?
- Have you worked directly with R&D, Quality, Regulatory Affairs, and Operations teams to support product launches?
Education:
Ability to Commute:
- Lake Mary, FL 32746 (Required)
Work Location: In person
