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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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.

 

The Quality Assurance department is responsible for all aspects of the quality assurance functions. The department’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.

 

Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.

 

Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

 

Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.

The position schedule: Fr-Sun 6:00am-6:30pm

 

Relationships

Reports to: Supervisor, QA.

 

Essential Functions

  

On-Floor Support (Drug Substance)

Accountable for execution of the QA on the Floor program

Partner with Manufacturing and other support teams

Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing

Review batch documents

Review and disposition of media/buffer formulation batches

Assist with revision of GMP documentation such as Standard Operating Procedures

Initiate incident description forms and/or deviations as required when observed on the floor

Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, formulation of media/buffer, and manufacture of bulk drug substance– 70% of day is spent on the floor

Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices

Provides QA support of Client Person in Plant (PIPs)

Make solid quality decisions with limited oversight escalating all process-stopping issues to area management and quality management

Acts as QA reviewer on Minor deviations

Identify continuous improvement initiatives

Participate in site and corporate quality and process improvement initiatives

Represent perspective as necessary

Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices

Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Assists and train colleagues on aseptic behavior, techniques, and best practices

Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite

Provide immediate feedback during routine observation to line leaders and colleagues, both positive practices and opportunities for improvement to allow for further development of colleague capabilities

Observe, coach and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impact processing

Analyze, develop, and improve quality systems and associated business processes to achieve compliance with global regulatory requirements

Perform investigations using root cause analysis tools and work with impacted areas on CAPAs to address root cause

Support investigation activities utilizing root-cause and problem-solving methodologies, including support of CAPA development and implementation

Develop and maintain department and site metrics for monitoring critical process and Quality attributes

Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects

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, batch records, and remain current with all training requirements

Other duties as assigned

  

 

Physical Requirements

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed. Walking and/or standing for up to 8 to 12 hours depending on assigned area. Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

 

Qualifications

Education/Experience:

Bachelor’s degree plus 2+  years of relevant experience required, or 5 years of experience of demonstrated excellence in role with justification, in lieu of the degree required

STEM Bachelor’s degree, highly preferred

1-year GxP/GMP experience or other regulated industry, required

Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies

Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures

Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects

Must be able to read and understand English-written job instructions and safety requirements

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

Technical Requirements:

Ability to use Excel, Word, and other office systems

Ability to learn and use quality management software such as TrackWise® or ComplianceWire®

Ability to understand and independently apply CGMPs to everyday work

Demonstrates understanding of the work tasks assigned

Executes procedures of moderate complexity with high quality

Intermediate understanding of pharmaceutical laboratory and/or production operations

Capable of learning unfamiliar principles or techniques with training

Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor

Ability to problem solve and execute and monitor corrective actions

Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions

Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor

Seeks best practices for daily work activities

Behavioral Requirements:

Ability to see and hear and read and write clear English

Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner

Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

Ability to cooperate with coworkers within an organized team environment or work alone

Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines

Ability to put aside personal opinions and focus on business needs, department needs or group needs

Ability to transfer knowledge to others via training or mentoring

Demonstrated ability to guide others thorough communication and learning

Ability to make decisions which have moderate impact on immediate work unit

Leadership Requirements:

Lead by example according to Catalent's values and culture

Builds on contacts and relationships with peers

Take initiative for personal and professional development

Takes initiative when necessary to address changes in scope and procedural errors

Builds trust and respect for self and department

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.