What are the responsibilities and job description for the FDA Compliance Manager position at Maine Oxy?
Job Title: FDA Compliance Manager
Department: Operations
FLSA Status: Non-Exempt
Location: New England
Reports To: COO
Position Overview
The FDA Compliance Manager at Maine Oxy ensures that all products, processes, and facilities comply with FDA regulations and guidelines. This role is crucial in maintaining the company's reputation for high-quality, safe products. The manager will provide leadership, training, and expertise on FDA compliance matters, overseeing audits, inspections, and documentation.
Key Responsibilities
- Monitor and interpret FDA regulations, guidelines, and enforcement trends to ensure company compliance.
- Implement and maintain FDA-compliant processes for products such as medical and food grade gases and any regulated equipment.
- Remain up to date on FDA guidelines.
- Develop, update, and enforce Standard Operating Procedures (SOPs) for FDA compliance and Maine Oxy’s FDA Manual.
- Collaborate with cross-functional teams to address regulatory concerns and implement corrective actions.
- Prepare for and lead FDA audits and inspections.
- Oversee HARPC Reporting for locations.
- Maintain thorough documentation to demonstrate compliance with FDA requirements.
- Oversee submission of required FDA reports, such as Annual Reports, Adverse Event Reporting, and other mandated filings.
- Train employees on FDA regulations, Good Manufacturing Practices (GMP), and company compliance policies.
- Serve as the point of contact for FDA regulatory matters, providing guidance to leadership and operational teams.
- Assess potential compliance risks and provide strategic recommendations to mitigate issues.
- Othe duties as assigned.
Qualifications and Skills
- Bachelor’s degree in related field.
- Minimum 2 years of experience in FDA compliance, ideally within the medical gases or pharmaceutical industries.
- Proven experience managing FDA inspections.
- Strong understanding of GMP and ISO standards.
- Excellent analytical, organizational, and project management skills.
- Effective communicator, with the ability to train and influence cross-functional teams.
- Detail-oriented and proactive in identifying and resolving compliance issues.
Physical Requirements
- Ability to sit, stand, and walk for extended periods while performing inspections or audits.
- Capability to lift and carry up to 25 pounds occasionally for handling documentation, equipment, or samples.
- Dexterity to operate a computer, phone, and other standard office equipment effectively.
- Occasional climbing, bending, or stooping may be required to access facilities, inspect equipment, or review production processes.
- Visual acuity to review detailed documentation and inspect product labeling or manufacturing operations.
- Will be required to visit various Maine Oxy facilities for audits or inspections.
About Maine Oxy
Originally founded in Auburn, ME we have expanded to 17 locations in New England, a distribution hub in Orlando, FL, and a distribution hub in Manalapan, NJ. We are a leading distributor of industrial, medical and specialty gases and a distributor of quality hard goods including welding and cutting equipment, supplies and accessories. Maine Oxy is an Equal Opportunity Employer.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
- Monday to Friday
Ability to Commute:
- Auburn, ME 04210 (Required)
Willingness to travel:
- 100% (Required)
Work Location: In person
