The JobSquad Solutions Team is currently looking for a Regulatory Technician to work at a company located in the Miramar, FL area!
| Job Title
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| Regulatory Technician
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| Position Location
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| Miramar Fl
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Pay/hours for position
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| $20 - $22/HR
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| Requirements of position
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- Education: Bachelor’s degree in life sciences, chemistry, pharmaceutical sciences, or a related field.
- Experience:
- 1–3 years of experience in a GMP-regulated environment (pharmaceutical, biotechnology, food, or medical devices).
- Experience in regulatory affairs or quality assurance is a plus.
- Skills:
- Strong knowledge of GMP regulations (FDA 21 CFR Part 210/211, EU GMP, ICH Q7, etc.).
- Excellent attention to detail and organizational skills.
- Ability to work collaboratively across departments.
- Proficiency in Microsoft Office and document control systems.
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| Job Summary:
The Regulatory Technician (GMP) is responsible for supporting regulatory compliance activities within a GMP-regulated environment. This includes assisting in documentation control, reviewing procedures, ensuring compliance with regulatory requirements, and supporting audits and inspections.
Key Responsibilities:
- Documentation & Compliance:
- Maintain and update GMP documentation, including standard operating procedures (SOPs), batch records, and technical files.
- Ensure all records comply with FDA, EMA, MHRA, or other relevant regulatory guidelines.
- Assist in reviewing and approving manufacturing and quality documents.
- Regulatory Support:
- Support regulatory submissions and product registration activities.
- Assist in preparing and compiling regulatory reports, summaries, and technical documents.
- Ensure compliance with cGMP, ICH guidelines, and company policies.
- Audit & Inspection Support:
- Assist in internal and external regulatory audits, including FDA, EMA, and other agency inspections.
- Help implement corrective and preventive actions (CAPA) based on audit findings.
- Quality & Risk Management:
- Monitor and report non-conformances and deviations.
- Support change control processes and risk assessments.
- Participate in GMP training programs and help maintain training records.
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