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 PM&TT organization supports the Bloomington facility through client-facing support, technical expertise, project management, and continuous improvement. The team is broken down into six key subgroups: Technical Project Management, Technical Subject Matter Experts (SMEs), Systems and Processes, Finance, Strategic Initiatives, and Technical Writing.
The Position
This position requires the coordination and writing of cGMP manufacturing batch records, change controls, and batch summary reports. Responsibilities include implementing revisions to the documents as advised by subject matter experts. The applicant is expected to possess a writing background, strong organizational skills, and a high attention to detail.
Relationships
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Essential Functions
Generates batch production records in accordance with applicable regulatory guidance and site Standard Operating Procedures (SOPs), with minimal technical understanding Authors procedures and reports of moderate complexity with high quality and minimum guidance Authors SOPs and Work Instructions with minimal technical understanding Authors and drive to completion Material Specification Sheets (MSSs) and Change Controls with minimal technical understanding Performs SME review of reports for completion and accuracy Responds to internal and client feedback; works with SMEs to ensure proper application Copy-edits documents in accordance with applicable regulatory guidance and site SOPs Supports other activities within the Technical Writing Group as assigned Communicates with stakeholders when necessary
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.
Qualifications
Education/Experience: Bachelor’s degree with 1+ years of work experience preferred, or Associate’s with 4 - 5 years role-relevant experience GMP experience preferred Must be able to read and understand English-written job instructions and safety requirements Technical Requirements: Applied knowledge of Word, Excel, PowerPoint, and other and applies technical knowledge to assist and train the site with Microsoft troubleshooting Has introductory knowledge of the principles, theories, and concepts of science Executes work plan/schedule developed with input from management Ability to understand and write assigned SOPs and moderately complex batch production records with minimal guidance Excellent written communications skills with internal customers Behavioral Requirements: Ability to write clear and succinct English Skilled in adaptability, analysis, decision making, critical thinking Highly dependable Demonstrates stress control in a high-pressure environment Ability to learn and retain technical information Mathematical and scientific reasoning ability Recognizes unmet needs within the department Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner Ability to manage time effectively to complete assignments in expected time frame Independently seeks out additional work when tasks are completed Ability to cooperate with coworkers within an organized team environment or work alone Positive attitude Ability to process a large volume of work
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.