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.
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.
The Position
This position requires the coordination and writing of cGMP manufacturing batch records or batch summary reports for platform processes. The position responsibilities will include addressing revisions to the documents, supported by subject matter experts. The position is expected to possess a scientific or writing background, strong organizational skills, and a high attention to detail. This position will involve multiple daily gowning and de-gowning procedures.
Schedule: Monday Friday 10:00pm - 6:30am
Relationships
Reports to: Supervisor, QC
Essential Functions
Responds to internal comments and works with SMEs to ensure comments are incorporatedExecutes procedures of moderate complexity with high quality with a minimum degree of guidanceSupport other activities within the Technical Writing Group as assignedBatch Production Record Technical WriterAuthors non-process batch production records (solution, column, bulk fill) to support cGMP manufacturing with minimal technical understandingGenerates batch production records in accordance with applicable regulator guidance and site SOPsReports Technical WriterAuthors platform documents from execution batch production records with minimal technical understandingCopy-edits documents in accordance with applicable regulator guidance and site SOPsPhysical 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. Safety procedures will be followed to minimize exposure, including clean room gowning.
Qualifications
HS/GED requiredAssociate's degree preferred1+ year of relevant experience preferredGMP experience, preferredMust be able to read and understand English-written job instructions and safety requirementsTechnical Requirements:Proficiency in computer usage is essential for this positionApplied knowledge of Word, Excel, PowerPoint, and other and applies technical knowledge to assist and train the site with Microsoft troubleshootingHas introductory knowledge of the principles, theories, and concepts of a disciplineExecutes work plan/schedule developed with input from senior team memberAbility to understand and write assigned SOPs and moderately complex batch production records with minimal guidanceExcellent written communications skills with internal customersAbility to address work issues at both an individual level and team levelBehavioral Requirements:Ability to see and hear, read, and write clear EnglishRequires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writingDemonstrates leadership capabilities in a matrix environmentAbility to learn and retain technical informationMathematical and scientific reasoning abilityRecognizes unmet needs within the departmentAbility 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 mannerAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of timeAbility to cooperate with coworkers within an organized team environment or work aloneDetail oriented with ability to work effectively under high pressure with multiple deadlinesStrong ability to multi-task in a fast-paced environmentPositive attitude and ability to work with othersAbility to process a large volume of workAbility to effectively carry out and implement changeAbility to put aside personal opinions and focus on business needs, department needs, or group needsWe 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.