Job Description

General Purpose:

Responsible for ensuring quality oversight throughout the production process. Involved in day-to-day compounding floor oversight and throughout facility. Ensuring compliance in all areas including but not limited to environmental monitoring, personnel monitoring and visual inspection protocols.

Production Quality Assurance Manager

• Provide initial review of batch records prior to quality assurance disposition
• Owner of visual investigation program and ensuring protocol meets all regulatory requirements
• Lead investigator on any OOS results for batch testing with 3rd party lab
• Ensure qualifications and training personnel is completed in timely manner for all sterile product staff
• Partner with quality assurance documentation department to ensure documentation of all training is completed.
• Assist in the sterile logbook reviews, training competencies and inspection walkthroughs
• Oversight over aseptic operations within the sterile department
• Participate as part of the deviation investigation team member and provide insight to corrective and preventative action protocols
• Ensuring policies and procedures are being followed at the pharmacy and meet all regulatory requirements
• Oversight over aseptic process simulation media fill program, confirming process meeting regulatory requirements and conducted in appropriate timeframes.
• Engage in internal and external audit processes

Job Tasks and Responsibilities

• Responsible and accountable for the performance and operation of the facility and personnel in the preparation of Hazardous and Non-Hazardous CSPs, Hazardous and Non-Hazardous CNSPs and for performing other functions as described in this procedure.
• Creating and implementing a training program for personnel and for ensuring that compounders, personnel who have direct oversight of compounders, and personnel who perform restocking or cleaning and disinfection duties are initially trained and qualified by demonstrating knowledge and competency in maintaining the quality of the sterile compounding environment, non-sterile compounding environment, and hazardous compounding environment before being allowed to perform their job functions independently. Training and observation may be performed by an assigned trainer.
• Responsible for ensuring that each area related to CSP and CNSP preparation meets the classified air quality standard appropriate for the activities to be conducted in that area.
• Ensure that the ISO Class 5 areas are located, operated, maintained, monitored, and certified to have appropriate air quality. Must ensure that the facility has formal, written QA and QC programs that establish a system of:
• Adherence to procedures
• Prevention and detection of errors and other quality problems
• Evaluation of complaints and adverse events
• Appropriate investigations and corrective actions
• Must review the overall QA and QC program at least once every 12 months.
• Responsible for reviewing all certification and recertification records.
• Must review all complaints to determine whether the complaint indicates a potential quality problem with the CNSP and/or CSP, and document this review on the complaint form.
• When a non-API component cannot be obtained from an FDA-registered facility, must select an acceptable and reliable source for the intended use.
• Must ensure that the filters used for sterilization of CSPs:
• Are chemically and physically compatible with all ingredients in the CSP
• Are chemically stable at the pressure and temperature conditions that will be used; and
• Have enough capacity to filter the required volumes
• Provide training on quality areas of environmental monitoring and personnel monitoring for sterile technicians and pharmacies.
• Identify training needs and organize training interventions to meet production quality standards.
• Provide feedback and coaching to sterile staff on environmental monitoring and personnel monitoring protocols.
• Assist in drafting quality assurance policies and procedures related to environmental monitoring and personnel monitoring.
• Evaluate adequacy of quality assurance standards.
• Assist in reviewing logbooks related to environmental monitoring and personnel monitoring protocols.
• Review the implementation and efficiency of quality and inspection systems.
• Document internal audits and other quality assurance activities.
• Collaborate with quality department to collect and compile statistical quality data.
• Analyze data to identify areas for improvement in the production quality system.
• Develop, recommend and aid in the monitoring of corrective and preventive actions.
• Prepare reports to communicate outcomes of production quality activities.

Education and Experience

• Bachelor’s Degree in a Scientific Discipline
• Experience with implementation of corrective action programs
• Product or industry-specific experience
• Strong computer skills including Microsoft Office and databases
• Knowledge of tools, concepts and methodologies of QA
• Knowledge of relevant regulatory requirements

About the Job:

· Monday through Friday 9am-6pm

· 7 paid holidays

· No weekends

· Health, dental and vision insurance

· PTO / Sick package

· 401k

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