AD, Quality Control Job at Boehringer Ingelheim in Gainesville
Boehringer Ingelheim, Gainesville, GA, United States
Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Associate Director, Quality Control provides leadership and technical direction by coordinating with others, the activities associated with the testing of viral and bacterial vaccines. This includes all steps of the manufacturing process according to the Regulations or requirements described in the Global Quality Guidance. This role is also responsible for developing a workforce that is quality focused that will maintain compliance and efficient QC processes.
Duties & Responsibilities Regularly monitors the testing capacities to support the production flows and ensures adequate resources to complete timely testing
May participate or facilitate problem solving when testing issues disrupt the production flow
Ensures Quality Control personnel have the proper skills which are demonstrated through defined qualification activities or studies by identifying core skills and tasks related to training requirements
Participates in the strategy development for new product transfers and equipment purchases in addition to long range planning for future equipment and facility needs
Participates in building budget for department expense and approve purchases
Ensures proper use of quality systems by monitoring deviation closure time, change controls, timely completion and thorough OOS investigations, good documentation practices, changes to facility documents, and overall compliance in the department
Participates in regulatory inspections and global/corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors
Requirements Masters in science related field or combination of a related undergraduate science degree and five to ten (5-10) years of relevant experience
Seven to ten (7-10) years of experience in biological manufacturing environment with focus in Quality or Analytical Research and Development
Thorough knowledge of 9 CFR
Demonstrated technical knowledge
Experience working with federal regulatory agencies
Proven leadership skills
Knowledge of EU GMP Preferred
Eligibility Requirements Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
#J-18808-Ljbffr
The Associate Director, Quality Control provides leadership and technical direction by coordinating with others, the activities associated with the testing of viral and bacterial vaccines. This includes all steps of the manufacturing process according to the Regulations or requirements described in the Global Quality Guidance. This role is also responsible for developing a workforce that is quality focused that will maintain compliance and efficient QC processes.
Duties & Responsibilities Regularly monitors the testing capacities to support the production flows and ensures adequate resources to complete timely testing
May participate or facilitate problem solving when testing issues disrupt the production flow
Ensures Quality Control personnel have the proper skills which are demonstrated through defined qualification activities or studies by identifying core skills and tasks related to training requirements
Participates in the strategy development for new product transfers and equipment purchases in addition to long range planning for future equipment and facility needs
Participates in building budget for department expense and approve purchases
Ensures proper use of quality systems by monitoring deviation closure time, change controls, timely completion and thorough OOS investigations, good documentation practices, changes to facility documents, and overall compliance in the department
Participates in regulatory inspections and global/corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors
Requirements Masters in science related field or combination of a related undergraduate science degree and five to ten (5-10) years of relevant experience
Seven to ten (7-10) years of experience in biological manufacturing environment with focus in Quality or Analytical Research and Development
Thorough knowledge of 9 CFR
Demonstrated technical knowledge
Experience working with federal regulatory agencies
Proven leadership skills
Knowledge of EU GMP Preferred
Eligibility Requirements Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
#J-18808-Ljbffr