What are the responsibilities and job description for the Bilingual Regulatory Affairs Associate (English and Spanish) position at 5TH HQ?
We are currently seeking a Bilingual Regulatory Affairs Associate (English/Spanish) for a manufacturing company in Davie, FL. This opportunity is ideal for candidates with a Science-related educational background, including recent graduates or individuals currently finishing their degree.
We are open to considering candidates whose academic background, technical knowledge, and potential can complement or substitute previous professional experience.
Davie, FL
Schedule: Monday – Friday
8:30 AM – 5:00 PM
Salary Range: $20 – $24/hr
Responsibilities:
- Develop, review, edit, and maintain controlled documentation such as:
- Standard Operating Procedures (SOPs)
- Forms and specifications
- Testing methods
- Validation reports
- Complaints and CAPA reports
- Protocols and deviations
- Laboratory notebooks
- Product monographs
- Certificates of Analysis templates
- Review and maintain Master Formulas.
- Coordinate document control systems and SOP distribution.
- Support Change Control processes and compliance activities.
- Prepare annual GMP training materials and coordinate training sessions.
- Coordinate vendor qualification audits and supplier documentation.
- Assist with customer and regulatory audits.
- Prepare regulatory documentation submissions as required.
- Maintain documentation databases, records, and archival systems.
- Ensure compliance with cGMP regulations and company procedures.
- Perform additional duties assigned by management.
Qualifications:
- Bachelor’s Degree in Science or related field preferred.
- Recent graduates or candidates currently completing their degree are encouraged to apply.
- Bilingual English/Spanish required.
- 1–3 years of experience preferred, but not required.
- Knowledge of GMP regulations preferred.
- Computer literate.
- Detail-oriented with strong organizational skills.
- Previous experience in Production, Quality Control, or Regulatory Affairs is a plus.
Benefits:
- Full-time opportunity.
- Professional growth potential.
- Stable work environment.
Salary : $20 - $24