REGULATORY & QUALITY ASSURANCE OFFICER
Ocean Springs, MS (Hybrid 2-3 days/wk)
($40k base plus bonus)
Personal Attributes required for this Job:
Communication Thoroughness
Interpersonal Awareness Independence
Results Driven Team Player
Individual working Time Management
Ability to Learn Adaptability
Initiative Flexibility
Critical Information-Seeking Efficiency Orientation
Concern for Standards Attention to Detail
Analytical Thinking Problem Solving
Responsibilities:
Review and process inquiries regarding quality concerns and notify Managers or other departments, as necessary. Ensure timely and effective communication and follow-up with customers and manufacturers, as necessary.
Under the guidance of the Regulatory Manager, ensure strict adherence to U.S. government agency rules and regulations as well as country-specific importing/exporting policies and regulations.
Maintain knowledge of all Regulatory agencies regulations; assist Regulatory Manager with companies compliance and Quality system compliance.
Assist in the maintenance, upkeep and updating of company Standard Operating Procedures, as needed to facilitate company compliance program.
Process and accurately complete any required regulatory documentation (COA, TSE, Declaration Certificates, Quality Complaints, Technical Inquiries, MSDS, Stability Requests, etc.) according to company policy and any government regulations. Maintain all documentation and files.
Perform internal audits, to include in-process inspections of product handling (Controlled Drug, HazMat, Cold Chain, etc.), product packing and product documentation.
Handle and process all product quality notice from regulatory agencies (recalls, warning letters, etc.), following company Standard Operating Procedures and management directives.
Monitor warehouse temperature monitoring and maintain all documentation.
Maintain all documentation requirements per governing regulations.
Any other duties assigned by your Manager.
Qualifications and Experience Needed:
Graduate, High School Diploma or GED. Some college is preferred.
Experience in regulatory, compliance, quality assurance, pharmaceuticals or some other related field (preferred)
Excellent oral and written communication skills.
Proficiency with Microsoft Office Suite.
Ability to multitask.
Attention to detail; organizational skills.
Self-starter with ability to work independently.
Forward-thinking and open-minded.
Strong problem solving and analytical skills.
Adaptability and versatility in a dynamic environment.
Ability to effectively work in a team environment while maintaining group morale and mutual respect.
Positive attitude and strong work ethic.
