REGULATORY & QUALITY ASSURANCE OFFICER
POST TITLE: REGULATORY & QUALITY ASSURANCE OFFICER
Personal Attributes required for this Job:
Communication skills, written and oral Thoroughness and Attention to Detail
Interpersonal Awareness Work Independently
Results Driven Team Player
Time Management Analytical / Logical Thinking
Adaptability Concern for Standards
Critical Information-Seeking Efficiency Orientation
Attention to Detail Problem solving
- Responsible for company’s Quality Assurance program, under guidance of Regulatory Manager, to ensure compliance of staff to company Standard Operating Procedures, Work Instructions, and forms.
- Maintain knowledge of Good Distribution Practices in connection with Pharmaceutical Wholesale distribution as governed by the State Board of Pharmacy and the USFDA.
- Assist in maintenance, upkeep, and updating of company Standard Operating Procedures, as needed, and to facilitate company compliance program, as directed by company senior management.
- Assist in daily, weekly, monthly or annual internal audits as directed by the Regulatory Manager.
- Perform monthly quality checks, to include: warehouse documentation, in-process inspections of product handling (Controlled Drug, HazMat, Cold Chain, etc.), product packing, and/or product documentation.
- Monitor warehouse temperature and humidity records and maintain all documentation regarding calibration of temperature recorders,
- Oversee product destruction and handle controlled drug product destruction. Maintain all product destruction records.
- Audit controlled drug job jackets to ensure that proper documentation is maintained per DEA regulations.
- Assist Regulatory Manager with External audits by regulatory agencies, customers, suppliers, etc. as needed.
- Any other duties assigned by your Manager
Qualifications and Experience Needed:
- Graduate, High School Diploma or GED. Some college preferred.
- Minimum 2 years’ experience in regulatory, compliance, quality assurance, pharmaceuticals or some other related field.
- Proficiency with Microsoft Office Suite
- 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