Fagron Group
About the Job
Responsible for oversight of onsite and outsourced Quality Control testing to ensure products and processes meet company and regulatory standards. Timely delivery of results to meet company and production objectives. Support of current and new product introduction validation, sample management, stability testing management, and equipment management. Pay: $120,000-$150,000 USD Annually Key Responsibilities
Manages the Quality Control staff to ensure appropriate coverage is maintained, the team is trained, and cross-trained to meet business needs. Ensure team and outsourced testing is performed in compliance with SOPs, cGMP, Safety regulations, and applicable FDA compendial methods. Ensure appropriate staff appointment and training. Manages staff performance and address issues in a timely, constructive and professional manner. Develops employees to better accomplish and perform in their duties as QC professionals, including developing training for the QC laboratories. Assumes QC responsibilities for major projects, such as new products or lab renovations. Projects related to computer system control of the laboratories. Actively participates in and supports Continuous Improvement initiatives. Responsible for the operation of the Microbiology Lab to ensure timely completion of sampling, testing and results reporting to meet production schedules. Manages the administration of the Quality Control Organization directly reporting to them. Provides QC budget input for future personnel, equipment, and facility needs. Participates in regulatory/FDA inspections. Ensures laboratory is prepared for inspections and manages any corrective actions necessary. Demonstrates understanding of Analytical and Microbiological testing methodology and equipment. Performs stability assessments, oversees the shipment of outsourced stability testing, and ensures timely completion of testing and sample analysis. Identifies and recommends sampling & testing equipment needs. Ensures appropriate equipment installation, validation, and operation. Reviews, assesses and approves Standard Operating Procedures, Protocols and reports such as stability reports, method validation, method transfer, process/assay validation. Manages the supplies and equipment calibration/PM execution to ensure materials are available to perform testing, equipment are calibrated / PM’d to ensure testing is not interrupted, and testing is able to be executed in a timely manner. Works independently of direct supervision; assumes responsibilities for the daily functional activities and has authority to approve documentation and make decisions for the facilities' QC department. Maintain an updated knowledge of QC and GMP trends. Implement improvement projects to drive increased flexibility and reduce costs. Oversee QC matters for the Micro lab, such as qualification of equipment, risk analyses, corrective actions, etc. Ensure compliance with all relevant cGMP and applicable corporate Quality System requirements. Participate in the development and/or review of QC including procedures, SOPs and other documents. In conjunction with the Quality Site Head and Operations, investigate all excursions and OOS situations at the facility and implement appropriate corrective actions. Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventive actions and appropriate effectiveness measures. Manages the preparation and review of any established metrics / KPIs for management. Manages testing and performance of Contract Test Laboratories. Basic Qualifications
Bachelor of Science Degree with 10–15 years related work experience including a minimum of 5 years of supervisory experience. An advanced degree is strongly preferred. Able to work collaboratively in a matrixed organization Position requires advanced training or experience in cGMPs and GLPs. Thorough knowledge of compendia USP guidelines. Demonstrated ability to establish and lead Environmental Monitoring programs. A very strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry as well as other legal requirements for business operations. Advanced computer skills. Excellent verbal and written communication skills required. Strong ability to identify and troubleshoot analytical problems. Knowledge 503B regulations a plus. What's on Offer?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
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Responsible for oversight of onsite and outsourced Quality Control testing to ensure products and processes meet company and regulatory standards. Timely delivery of results to meet company and production objectives. Support of current and new product introduction validation, sample management, stability testing management, and equipment management. Pay: $120,000-$150,000 USD Annually Key Responsibilities
Manages the Quality Control staff to ensure appropriate coverage is maintained, the team is trained, and cross-trained to meet business needs. Ensure team and outsourced testing is performed in compliance with SOPs, cGMP, Safety regulations, and applicable FDA compendial methods. Ensure appropriate staff appointment and training. Manages staff performance and address issues in a timely, constructive and professional manner. Develops employees to better accomplish and perform in their duties as QC professionals, including developing training for the QC laboratories. Assumes QC responsibilities for major projects, such as new products or lab renovations. Projects related to computer system control of the laboratories. Actively participates in and supports Continuous Improvement initiatives. Responsible for the operation of the Microbiology Lab to ensure timely completion of sampling, testing and results reporting to meet production schedules. Manages the administration of the Quality Control Organization directly reporting to them. Provides QC budget input for future personnel, equipment, and facility needs. Participates in regulatory/FDA inspections. Ensures laboratory is prepared for inspections and manages any corrective actions necessary. Demonstrates understanding of Analytical and Microbiological testing methodology and equipment. Performs stability assessments, oversees the shipment of outsourced stability testing, and ensures timely completion of testing and sample analysis. Identifies and recommends sampling & testing equipment needs. Ensures appropriate equipment installation, validation, and operation. Reviews, assesses and approves Standard Operating Procedures, Protocols and reports such as stability reports, method validation, method transfer, process/assay validation. Manages the supplies and equipment calibration/PM execution to ensure materials are available to perform testing, equipment are calibrated / PM’d to ensure testing is not interrupted, and testing is able to be executed in a timely manner. Works independently of direct supervision; assumes responsibilities for the daily functional activities and has authority to approve documentation and make decisions for the facilities' QC department. Maintain an updated knowledge of QC and GMP trends. Implement improvement projects to drive increased flexibility and reduce costs. Oversee QC matters for the Micro lab, such as qualification of equipment, risk analyses, corrective actions, etc. Ensure compliance with all relevant cGMP and applicable corporate Quality System requirements. Participate in the development and/or review of QC including procedures, SOPs and other documents. In conjunction with the Quality Site Head and Operations, investigate all excursions and OOS situations at the facility and implement appropriate corrective actions. Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventive actions and appropriate effectiveness measures. Manages the preparation and review of any established metrics / KPIs for management. Manages testing and performance of Contract Test Laboratories. Basic Qualifications
Bachelor of Science Degree with 10–15 years related work experience including a minimum of 5 years of supervisory experience. An advanced degree is strongly preferred. Able to work collaboratively in a matrixed organization Position requires advanced training or experience in cGMPs and GLPs. Thorough knowledge of compendia USP guidelines. Demonstrated ability to establish and lead Environmental Monitoring programs. A very strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry as well as other legal requirements for business operations. Advanced computer skills. Excellent verbal and written communication skills required. Strong ability to identify and troubleshoot analytical problems. Knowledge 503B regulations a plus. What's on Offer?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
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