Johnson & Johnson companies are equal opportunity employers.
QA Supervisor/ Team Leader-6873140325
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QA Supervisor/Team Leader, located in Lancaster, Pennsylvania.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The QA Supervisor/Team Leader provides daily direction, planning and compliance focus to the Process Review Team consistent with the supply chain’s goals, while meeting the compliance goals of Quality Assurance. Provides compliance perspective and expertise to ensure that the process consistently meets all internal and Regulatory Quality standards. Measures, tracks, trends and promotes improvement of process metrics. Facilitates resolution of issues to improve site metrics. Provides training and direction as needed to direct reports and guidance on setting objectives, frequent feedback and timely performance reviews to direct reports.
Process Focus - Strives to achieve successful day-to-day process outcomes for the entire process from receiving of materials through to shipment of finished products to the DC’s. Participate actively as a member of the Process Review Team (PRT) in daily and weekly meetings. Participates actively in PRT efforts to investigate and resolve day-to-day compliance, process, technical and quality issues. Participates in daily PRT ‘Walk-through’. Participates on project teams as needed.
Compliance Focus - Provides real-time compliance consulting and expertise to the site. Ensures appropriate focus on compliance goals and issues at DCM and PRT meetings. Acts as signatory on compliance documentation – including (but not limited to) Quality Notifications (Investigations), Change Controls, Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Packaging Line Trials (PLTs), Equipment IQ/OQ/PQ Protocols and Reports, and Annual Product Reviews (APRs). Actively supports compliance improvement and training initiatives.
Customer and Performance Improvement Focus - Ensures the visual board system is up-to-date with the most current information on product in process. Measure, track, trend and promote improvement of process metrics. Facilitate resolution of issues to improve site metrics.
People & Organization Focus - Provides training and direction as needed to direct reports. Provides guidance on setting objectives, frequent feedback and timely performance reviews to direct reports. Teams with Managers to meet recruitment needs of Compliance Group and the PRT.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of B.S. or B.A. degree is required. A focus degree in science or technical field is preferred. A minimum of 5 years pharmaceutical, quality or any regulated industry experience, with proven success in quality systems/compliance improvement is required. Active cGMP interpretation and application experience is required. Demonstrated leadership- possesses the ability to lead a team is preferred. Strong organizational skills and strong communication/interpersonal and facilitation Skills (verbal, written and presentation) is required. Experience in problem solving, investigation, conformance is required. Expertise in handling multiple priorities is required. Project management experience preferred. Process and systems experience, especially with SOPs, MBRs, Change Controls and Validation is preferred
This candidate will be based in Lancaster, PA and will be required to travel less than 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
QA Supervisor/ Team Leader-6873140325
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a QA Supervisor/Team Leader, located in Lancaster, Pennsylvania.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The QA Supervisor/Team Leader provides daily direction, planning and compliance focus to the Process Review Team consistent with the supply chain’s goals, while meeting the compliance goals of Quality Assurance. Provides compliance perspective and expertise to ensure that the process consistently meets all internal and Regulatory Quality standards. Measures, tracks, trends and promotes improvement of process metrics. Facilitates resolution of issues to improve site metrics. Provides training and direction as needed to direct reports and guidance on setting objectives, frequent feedback and timely performance reviews to direct reports.
Process Focus - Strives to achieve successful day-to-day process outcomes for the entire process from receiving of materials through to shipment of finished products to the DC’s. Participate actively as a member of the Process Review Team (PRT) in daily and weekly meetings. Participates actively in PRT efforts to investigate and resolve day-to-day compliance, process, technical and quality issues. Participates in daily PRT ‘Walk-through’. Participates on project teams as needed.
Compliance Focus - Provides real-time compliance consulting and expertise to the site. Ensures appropriate focus on compliance goals and issues at DCM and PRT meetings. Acts as signatory on compliance documentation – including (but not limited to) Quality Notifications (Investigations), Change Controls, Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Packaging Line Trials (PLTs), Equipment IQ/OQ/PQ Protocols and Reports, and Annual Product Reviews (APRs). Actively supports compliance improvement and training initiatives.
Customer and Performance Improvement Focus - Ensures the visual board system is up-to-date with the most current information on product in process. Measure, track, trend and promote improvement of process metrics. Facilitate resolution of issues to improve site metrics.
People & Organization Focus - Provides training and direction as needed to direct reports. Provides guidance on setting objectives, frequent feedback and timely performance reviews to direct reports. Teams with Managers to meet recruitment needs of Compliance Group and the PRT.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of B.S. or B.A. degree is required. A focus degree in science or technical field is preferred. A minimum of 5 years pharmaceutical, quality or any regulated industry experience, with proven success in quality systems/compliance improvement is required. Active cGMP interpretation and application experience is required. Demonstrated leadership- possesses the ability to lead a team is preferred. Strong organizational skills and strong communication/interpersonal and facilitation Skills (verbal, written and presentation) is required. Experience in problem solving, investigation, conformance is required. Expertise in handling multiple priorities is required. Project management experience preferred. Process and systems experience, especially with SOPs, MBRs, Change Controls and Validation is preferred
This candidate will be based in Lancaster, PA and will be required to travel less than 10% domestically.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement