Verified Job
Clerical - Administrative
FDA Compliance Officer
Clerical - Administrative
#774293
Remote / WFH
Optima Multivitamins USA
Job Description
Job details
$55,943.92 - $67,373.33 a year
Contract, Full-time
9000 Richmond Avenue, Houston, TX 77063
Match overview
Here's how the job details align with your profile.
Qualifications: 0 of 1
Customer complaint resolution
Full job description
Overview
Optima Multivitamins is seeking an experienced FDA Compliance Officer to manage regulatory compliance and inspection readiness for our dietary supplement distribution facility.
The ideal candidate will have practical experience with FDA dietary supplement regulations, 21 CFR Part 111, warehouse and distribution compliance, standard operating procedures, complaints, adverse events, recalls, labeling, and quality documentation.
Duties
Maintain FDA inspection readiness.
Serve as the primary internal coordinator during FDA inspections.
Develop, update, and control standard operating procedures, forms, and compliance records.
Monitor receiving, storage, sanitation, quarantine, distribution, return, damaged-product, and expiration controls.
Maintain product and lot traceability.
Review temperature, humidity, sanitation, pest-control, and warehouse records.
Manage product complaint reviews and investigations.
Evaluate adverse events and serious adverse events.
Coordinate required FDA reporting.
Manage recalls, mock recalls, effectiveness checks, reconciliation, and product disposition.
Review dietary supplement labels, website content, marketplace listings, and promotional claims.
Maintain supplier, contract manufacturer, laboratory, warehouse, and fulfillment-provider documentation.
Investigate deviations and manage corrective and preventive actions.
Conduct employee training and internal compliance audits.
Qualifications
Experience with FDA-regulated dietary supplements.
Working knowledge of 21 CFR Part 111.
Experience with holding, storage, distribution, or warehouse compliance.
Experience preparing standard operating procedures and inspection records.
Knowledge of complaints, adverse events, recalls, labeling, and product traceability.
Strong attention to detail, documentation, communication, and investigation skills.
Bachelor’s degree in regulatory affairs, quality assurance, food science, chemistry, biology, pharmacy, public health, business operations, supply chain, or a related field preferred.
Minimum Experience: 3-5 years
To Apply
Submit your resume with a summary of your FDA dietary supplement compliance experience. Optima Multivitamins is an equal opportunity employer.
Pay: $55,943.92 - $67,373.33 per year
Work Location: In person
$55,943.92 - $67,373.33 a year
Contract, Full-time
9000 Richmond Avenue, Houston, TX 77063
Match overview
Here's how the job details align with your profile.
Qualifications: 0 of 1
Customer complaint resolution
Full job description
Overview
Optima Multivitamins is seeking an experienced FDA Compliance Officer to manage regulatory compliance and inspection readiness for our dietary supplement distribution facility.
The ideal candidate will have practical experience with FDA dietary supplement regulations, 21 CFR Part 111, warehouse and distribution compliance, standard operating procedures, complaints, adverse events, recalls, labeling, and quality documentation.
Duties
Maintain FDA inspection readiness.
Serve as the primary internal coordinator during FDA inspections.
Develop, update, and control standard operating procedures, forms, and compliance records.
Monitor receiving, storage, sanitation, quarantine, distribution, return, damaged-product, and expiration controls.
Maintain product and lot traceability.
Review temperature, humidity, sanitation, pest-control, and warehouse records.
Manage product complaint reviews and investigations.
Evaluate adverse events and serious adverse events.
Coordinate required FDA reporting.
Manage recalls, mock recalls, effectiveness checks, reconciliation, and product disposition.
Review dietary supplement labels, website content, marketplace listings, and promotional claims.
Maintain supplier, contract manufacturer, laboratory, warehouse, and fulfillment-provider documentation.
Investigate deviations and manage corrective and preventive actions.
Conduct employee training and internal compliance audits.
Qualifications
Experience with FDA-regulated dietary supplements.
Working knowledge of 21 CFR Part 111.
Experience with holding, storage, distribution, or warehouse compliance.
Experience preparing standard operating procedures and inspection records.
Knowledge of complaints, adverse events, recalls, labeling, and product traceability.
Strong attention to detail, documentation, communication, and investigation skills.
Bachelor’s degree in regulatory affairs, quality assurance, food science, chemistry, biology, pharmacy, public health, business operations, supply chain, or a related field preferred.
Minimum Experience: 3-5 years
To Apply
Submit your resume with a summary of your FDA dietary supplement compliance experience. Optima Multivitamins is an equal opportunity employer.
Pay: $55,943.92 - $67,373.33 per year
Work Location: In person
