Representative, Quality Assurance - Change Controls
BioSpace
Date: 6 hours ago
City: Bloomington, IN
Contract type: Full time
About The Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
What We Offer You
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
QA Representative – Change Controls
The QA Representative’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients.
Essential Functions
Facilitate and maintain the site change control process in compliance with FDA, EU GMP, and other regulatory guidelines.
Manage change control records within the electronic quality management system and ensure timely review and closure.
Facilitate the Change Control Board (CCB) activities, ensuring thorough review and deci-sion-making regarding change risks, impacts, and action plans.
Collaborate with cross-functional teams, including Manufacturing, Quality, and Regula-tory, to ensure change controls are well-documented, traceable, and compliant.
Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes
Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations
Maintains a sufficient understanding of the quality systems and operations
Assist with revision of GMP documentation such as Standard Operating Procedures
Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment
Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner
Follow all SOPs, cGMPs, and remain current with all training requirements
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Other duties as assigned
Physical Requirements
100% onsite at the Bloomington, Indiana site.
Qualifications
Bachelor's degree and 2+ years of experience or Master's degree and 0+ years of experience required
Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred
A strong working knowledge of quality systems and processes, preferred
GxP experience or other regulated industry, required
Technical Requirements
Ability to use Excel, Word, and other office systems, required
Ability to learn and use quality management software such as TrackWise or ComplianceWire, required
Ability to understand and independently apply CGMPs to everyday work, required
Intermediate understanding of pharmaceutical laboratory and/or production operations, required
Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor, required
Ability to problem solve and execute and monitor corrective action, required
Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions, required
Must be able to read and understand English-written job instructions and safety requirements, required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
What We Offer You
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
QA Representative – Change Controls
The QA Representative’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients.
Essential Functions
Facilitate and maintain the site change control process in compliance with FDA, EU GMP, and other regulatory guidelines.
Manage change control records within the electronic quality management system and ensure timely review and closure.
Facilitate the Change Control Board (CCB) activities, ensuring thorough review and deci-sion-making regarding change risks, impacts, and action plans.
Collaborate with cross-functional teams, including Manufacturing, Quality, and Regula-tory, to ensure change controls are well-documented, traceable, and compliant.
Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes
Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations
Maintains a sufficient understanding of the quality systems and operations
Assist with revision of GMP documentation such as Standard Operating Procedures
Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment
Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner
Follow all SOPs, cGMPs, and remain current with all training requirements
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Other duties as assigned
Physical Requirements
100% onsite at the Bloomington, Indiana site.
Qualifications
Bachelor's degree and 2+ years of experience or Master's degree and 0+ years of experience required
Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred
A strong working knowledge of quality systems and processes, preferred
GxP experience or other regulated industry, required
Technical Requirements
Ability to use Excel, Word, and other office systems, required
Ability to learn and use quality management software such as TrackWise or ComplianceWire, required
Ability to understand and independently apply CGMPs to everyday work, required
Intermediate understanding of pharmaceutical laboratory and/or production operations, required
Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor, required
Ability to problem solve and execute and monitor corrective action, required
Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions, required
Must be able to read and understand English-written job instructions and safety requirements, required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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