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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr