Pharmaceutical Quality Analyst
The Quality Analyst is a meticulous and detail-oriented team member performing in the quality and regulatory areas.
This role will be responsible for overseeing quality control processes under the quality director in both 503A and 503B compounding operations.
The Quality Analyst will collaborate with various departments to identify areas for improvement, enhance quality, and ensure strict adherence to regulatory requirements.
Key
Responsibilities:
Quality Assurance:
Perform comprehensive quality checks on compounded medications to guarantee they meet or exceed established quality standards for both 503A and 503B operations, employing Quality by Design principles to ensure product quality and consistency.
Validation and Qualification:
Lead validation and qualification activities for equipment, processes, and systems within both compounding facilities, ensuring compliance with sBOP, USP, or cGMP requirements and industry best practices.
Data Analysis:
Analyze data and reports to detect trends, anomalies, and potential areas for improvement in both compounding facilities, utilizing statistical techniques and process capability analysis.
Process Evaluation:
Evaluate compounding processes to identify inefficiencies and recommend enhancements that optimize product quality and operational efficiency for both 503A and 503B compounding, all within the framework of a robust Quality Management System (QMS).
Documentation:
Maintain accurate and up-to-date records of quality control tests, findings, validations, qualifications, and SOPs, ensuring compliance with regulatory requirements and QMS documentation standards.
SOP Management:
Develop, review, and update Standard Operating Procedures (SOPs) related to quality control and compounding processes, in accordance with regulatory standards and process controls.
Training:
Provide training and guidance to compounding staff on quality control processes, validation, qualification requirements, and adherence to SOPs, ensuring that 503A and 503B facilities align with best practices and regulatory requirements.
Compliance:
Ensure that both 503A and 503B facilities comply with all applicable industry regulations, including USP standards and cGMP, within the context of a comprehensive QMS and process controls.
Problem Solving:
Investigate quality-related incidents or concerns and collaborate with teams to identify root causes and implement corrective and preventive actions in both compounding settings, following established QMS procedures.
Process Controls:
Implement and monitor process controls to ensure the consistency and quality of compounded medications, continuously improving processes within the framework of the QMS.
Reporting:
Generate regular quality performance reports for both 503A and 503B operations, presenting findings to management and relevant departments, and integrating them into the QMS for continuous improvement.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SKILLS AND ABILITIES:
Ability to work and communicate well with pharmacist, peers, and superiors in a cordial and professional manner.
Excellent listening and communication skillsMust be detail-oriented and inclined to make few mistakes.
Committed to close follow-up and completion of all assigned tasks.
Demonstrate teamwork and initiative.
Ability to complete tasks in a timely manner.
TECHNICAL SKILLS:
Ability to understand Microsoft Office software, QS-1, CompounderAbility to operate basic office equipment such as copier, fax, telephoneEDUCATION:
Bachelor's Degree
Experience:
Requires 5 to 7 years of quality experience Recommended Skills Good Manufacturing Practices Certified Global Meeting Planner Raw Materials Quality Management Systems Technical Services Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
This role will be responsible for overseeing quality control processes under the quality director in both 503A and 503B compounding operations.
The Quality Analyst will collaborate with various departments to identify areas for improvement, enhance quality, and ensure strict adherence to regulatory requirements.
Key
Responsibilities:
Quality Assurance:
Perform comprehensive quality checks on compounded medications to guarantee they meet or exceed established quality standards for both 503A and 503B operations, employing Quality by Design principles to ensure product quality and consistency.
Validation and Qualification:
Lead validation and qualification activities for equipment, processes, and systems within both compounding facilities, ensuring compliance with sBOP, USP, or cGMP requirements and industry best practices.
Data Analysis:
Analyze data and reports to detect trends, anomalies, and potential areas for improvement in both compounding facilities, utilizing statistical techniques and process capability analysis.
Process Evaluation:
Evaluate compounding processes to identify inefficiencies and recommend enhancements that optimize product quality and operational efficiency for both 503A and 503B compounding, all within the framework of a robust Quality Management System (QMS).
Documentation:
Maintain accurate and up-to-date records of quality control tests, findings, validations, qualifications, and SOPs, ensuring compliance with regulatory requirements and QMS documentation standards.
SOP Management:
Develop, review, and update Standard Operating Procedures (SOPs) related to quality control and compounding processes, in accordance with regulatory standards and process controls.
Training:
Provide training and guidance to compounding staff on quality control processes, validation, qualification requirements, and adherence to SOPs, ensuring that 503A and 503B facilities align with best practices and regulatory requirements.
Compliance:
Ensure that both 503A and 503B facilities comply with all applicable industry regulations, including USP standards and cGMP, within the context of a comprehensive QMS and process controls.
Problem Solving:
Investigate quality-related incidents or concerns and collaborate with teams to identify root causes and implement corrective and preventive actions in both compounding settings, following established QMS procedures.
Process Controls:
Implement and monitor process controls to ensure the consistency and quality of compounded medications, continuously improving processes within the framework of the QMS.
Reporting:
Generate regular quality performance reports for both 503A and 503B operations, presenting findings to management and relevant departments, and integrating them into the QMS for continuous improvement.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SKILLS AND ABILITIES:
Ability to work and communicate well with pharmacist, peers, and superiors in a cordial and professional manner.
Excellent listening and communication skillsMust be detail-oriented and inclined to make few mistakes.
Committed to close follow-up and completion of all assigned tasks.
Demonstrate teamwork and initiative.
Ability to complete tasks in a timely manner.
TECHNICAL SKILLS:
Ability to understand Microsoft Office software, QS-1, CompounderAbility to operate basic office equipment such as copier, fax, telephoneEDUCATION:
Bachelor's Degree
Experience:
Requires 5 to 7 years of quality experience Recommended Skills Good Manufacturing Practices Certified Global Meeting Planner Raw Materials Quality Management Systems Technical Services Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
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