Qa specialist [h1.location_city]

5th HQ -

Bilingual Regulatory Technician – (cGMP / FDA Compliance)

Location :  Miramar, FL

Schedule :  Monday - Friday :

6 : 00am - 2 : 30pm

2 : 30pm - 11 : 00pm

Pay Rate :   $20.00 - $23.00

About the Role :

We are seeking a  detail-oriented and highly organized Regulatory Technician  to join our Quality and Compliance team. This position is responsible for ensuring compliance with  FDA regulations (21 CFR Part 111)  and maintaining all regulatory documentation related to the  manufacturing, packaging, labeling, and holding  of dietary supplements.

The ideal candidate will have a strong background in  technical documentation, regulatory compliance, and cGMP practices , as well as solid knowledge of quality systems in a manufacturing environment.

Minimum Qualifications :

Associate or Bachelor’s degree  in  Chemistry, Biology, Pharmaceutical Sciences, Food Science, or a related field  (from the U.S. or a foreign institution).

Prior experience in  pharmaceutical, nutraceutical, or food manufacturing  preferred.

cGMP training and / or experience  in a controlled manufacturing environment.

Strong  technical writing and communication skills  (English required; bilingual a plus).

Ability to manage multiple projects and meet deadlines.

Proficiency in  Microsoft Office (Word, Excel, PowerPoint)  and familiarity with  ERP systems .

Key Responsibilities :

Ensure compliance with  FDA 21 CFR Part 111  regulations for manufacturing, packaging, labeling, and holding operations.

Maintain and update all  regulatory documentation, certifications, licenses, and permits .

Review and approve labeling and packaging materials for regulatory compliance.

Act as  Regulatory Intelligence , staying current on FDA regulations and industry updates.

Prepare and maintain  customer quality questionnaires  and technical documentation.

Collaborate with management and department heads to update procedures and SOPs.

Maintain and control the  issuance, storage, and return of labels  within the packaging department.

Coordinate and conduct  GMP training sessions  and maintain training records.

Prepare  technical submissions  for international product registrations.

Support the management of  trademarks, registrations, and patents .

Why Join Us :

Competitive compensation and benefits.

Opportunity to grow within a regulatory and quality-driven environment.

Dynamic, supportive team culture focused on compliance and excellence.