Regulatory Affairs Manager jobs in Olive Branch, MS

Job Description

The Quality and Regulatory Services Manager will perform the quality and regulatory affairs, duties, and responsibilities by reviewing department procedures, forms, training documents, product and equipment quality control (QC), change control processes, and validations, and assist with the development, as necessary. Perform all other duties as assigned.

Duties and Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position. All employees must perform all assigned duties in compliance with internal SOPs, external regulations, and internal policies, bring compliance issues to management’s attention, and assure quality customer service to all customers internal and external. Employees must comply with traffic legislation, be conscious of road safety, demonstrate safe driving, and other good road safety habits while driving their personal vehicle for work purposes.

• Develop, perform, and report departmental system audits and safety inspections
• Reviews applicable regulations and standards from FDA, AABB, CLIA, OSHA, NRC, State of Tennessee, and manufacturers to ensure compliance
• Suggests updates and executes the facility’s Quality Plan
• Personnel Training: Perform Good Manufacturing Practice (cGMP) and safety training and assist in inter-departmental training and competency evaluation
• Maintain compliance by enforcing applicable regulations and standards set by regulatory agencies and submit appropriate reports when required
• Document Control: Maintain proficiency in Document Control within MediaLab. Able to revise and create SOPs, Forms, and Job Aids
• Perform Equipment Management
• Create, perform, and review validations
• Manage the overall deviation management program to include investigation, root cause, analysis, corrective and preventative actions, and documentation
• Responsible for developing, tracking, monitoring, and reporting quality indicators
• Monitor and conduct trend analysis of quality indicators
• Process improvement, including change control and corrective/preventative actions
• Coordinate and assist in maintaining safety and risk management functions that the operational and administrative departments of the blood center perform
• Demonstrates knowledge and understanding of safety and disaster plan policies
• Manages new project / product execution for quality-related functions
• Assist in external inspections as necessary
• Support the Director of Quality and Regulatory Services
• Evaluation of positive test results and lookback
• Conduct donor counseling
• Assures Donor Record Forms are reviewed / audited
• Establishes and maintains cooperative working relationships with donors, hospital personnel, and other employees
• Supports the QRS Mission Statement
• Manage staff. Examples include: Running the Change Control meeting, coordinating and managing the Variance meeting, and assigning audit assignments
• Serves as General Supervisor as necessary
• Act as a backup if Director of Quality and Regulatory Services is unavailable

Required Qualifications

Education: Medical Technologist / Medical Laboratory Technician/Clinical Laboratory- strongly preferred. State of Tennessee Lab License

Preferred Qualifications

Education: Medical Technologist/Medical Laboratory Technician or SBB, CQA, RN. State of Tennessee Supervisor License

Experience: At least 2 years in Blood Banking/Laboratory or Manufacturing with familiarity of cGMP/Safety/OSHA Regulations.

Preferred 5 years in Blood Banking/Laboratory or Manufacturing with familiarity of cGMP/Safety/OSHA Regulations.