Technical Services Documentation Specialist

Overview
The Technical Services Documentation Specialist is responsible for the creation, revision, and management of technical documentation within a pharmaceutical or nutraceutical manufacturing environment, with a focus on softgel production. This role ensures compliance with regulatory requirements, quality standards, and operational procedures while supporting cross-functional teams such as production, quality assurance, customer service, purchasing, and R&D.

Key Responsibilities:

1. Documentation Development & Management

•  Create, review, revise, and maintain Standard Operating Procedures (SOPs), specifications, batch records, master formulas, protocols, and reports.

•  Develop and implement document control systems to ensure accessibility and compliance with Good Documentation Practices (GDP).

•  Maintain accurate and up-to-date records of manufacturing processes and procedures, ensuring adherence to FDA, GMP, and other applicable regulatory standards.

2. Support for Technical Services

•  Assist in preparing technical documents related to product development, validation, and technology transfer projects.

•  Collaborate with production and quality teams to gather data and resolve documentation discrepancies.

•  Ensure accurate documentation of deviations, investigations, and corrective/preventive actions (CAPAs).

3. Regulatory & Compliance Support

•  Support internal and external audits by providing necessary documentation and records.

•  Ensure that all documentation meets regulatory compliance standards, including FDA, EMA, and other global regulations.

•  Update documents in response to regulatory changes, customer requirements, or process improvements.

4. Cross-functional Collaboration

• Serve as a liaison between manufacturing, R&D, quality, and regulatory teams to ensure seamless documentation processes.

•  Provide training and guidance on documentation standards and GDP to relevant staff.

•  Participate in change control processes and ensure timely updates to impacted documents.

5. Continuous Improvement

• Identify opportunities to streamline documentation processes and improve efficiency.

•  Implement and manage electronic documentation systems, when applicable.

•  Monitor trends and provide feedback to ensure continuous compliance with industry best practices.

Education & Experience

•  Bachelor’s degree in a relevant field (e.g., pharmaceutical sciences, engineering, or life sciences).

•  2–5 years of experience in documentation management within the pharmaceutical or nutraceutical industry.

•  Familiarity with softgel manufacturing processes is highly preferred.

Technical Skills

•  Strong knowledge of GMP, GDP, FDA regulations, and ISO standards.

•  Proficiency with documentation systems and software (e.g., Microsoft Office, document control software).

•  Experience with electronic documentation systems is a plus.

Soft Skills

•  Exceptional organizational and time-management skills.

•  Detail-oriented with strong analytical and problem-solving abilities.

•  Excellent written and verbal communication skills.

•  Ability to work collaboratively in a fast-paced, cross-functional environment

•  Ability to meet deadlines as required.

Job Type: Full-time

Pay: $47,500.00 - $53,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Ability to Relocate:

• Miami, FL 33186: Relocate before starting work (Required)

Work Location: In person

Salary : $47,500 - $53,000