What are the responsibilities and job description for the Technician II, QC CLT position at BioSpace?
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
Responsibilities
The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the facility. The QC team is comprised of the following groups:
Microbiology: Microbiology testing such as, microbial enumeration testing and endotoxin testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
Environmental Monitoring: Evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products by performing routine and investigational sampling of the manufacturing environment and associated facilities.
Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.
Release and In-Process: Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
Method Validation: Analytical testing, data analysis, document writing, and data reporting to support phase appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.
Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.
Raw Materials: Material inspection, sampling, analytical testing, data analysis, document writing, and data reporting to support the qualification and release of raw materials and components for use in the manufacturing of bulk drug substance and drug product.
Other functions: Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly support the entire Quality Control department while performing their specific job functions.
This position requires a variety of skills necessary for biotech company operations. The position is an entry level Technician role with the expectation that the candidate can be trained on technical procedures and once trained, execute them consistently and reliably. Additionally, this position may support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. This position will support quality inspection of material arriving at the facility in a variety of environments (warehouse, office, and cleanroom).
Schedule: 2nd shift: Monday - Friday 10:00am-6:30pm
Relationships
Reports to: Supervisor, QC
Essential Functions
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. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.
Qualifications
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.
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
Responsibilities
The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the facility. The QC team is comprised of the following groups:
Microbiology: Microbiology testing such as, microbial enumeration testing and endotoxin testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
Environmental Monitoring: Evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products by performing routine and investigational sampling of the manufacturing environment and associated facilities.
Stability: Analytical testing, data analysis, document writing, and data reporting to support of ICH stability studies to determine the stability of bulk drug substance and drug product.
Release and In-Process: Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
Method Validation: Analytical testing, data analysis, document writing, and data reporting to support phase appropriate method validation of analytical methods. These methods directly support the Stability and Release and In-Process testing teams.
Sample Management: Management and oversight for all samples that support manufacturing, stability, and method validation. Also responsible for the management of stability chambers and oversight of laboratory critical reagents.
Raw Materials: Material inspection, sampling, analytical testing, data analysis, document writing, and data reporting to support the qualification and release of raw materials and components for use in the manufacturing of bulk drug substance and drug product.
Other functions: Additional functions within the Quality Control department include technical data review, training, instrument maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly support the entire Quality Control department while performing their specific job functions.
This position requires a variety of skills necessary for biotech company operations. The position is an entry level Technician role with the expectation that the candidate can be trained on technical procedures and once trained, execute them consistently and reliably. Additionally, this position may support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. This position will support quality inspection of material arriving at the facility in a variety of environments (warehouse, office, and cleanroom).
Schedule: 2nd shift: Monday - Friday 10:00am-6:30pm
Relationships
Reports to: Supervisor, QC
Essential Functions
- Performs general lab housekeeping in adherence to 5S standards including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering, and stocking supplies
- Stages materials/components for use within cGMP Quality Control lab
- Accurately completes routine and preventive maintenance on simple equipment. Perform facility monitoring of gas and water sampling
- Log in samples into laboratory tracking software
- Actively participates in team meetings and/or training sessions
- Perform quality inspection of material and take samples as instructed by written specifications to support production
- Other duties as assigned
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. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.
Qualifications
- Education/Experience:
- High School/GED required
- 2-5 years of industry experience preferred
- Technical Certificate or higher preferred
- Must be able to read and understand English-written job instructions and safety requirements
- Preferred:
- Familiarity with clean room procedure, aseptic technique, and general lab equipment experience
- cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge
- Experience following standard operating procedures (SOP)
- General laboratory equipment experience, including micropipettes
- Technical Requirements:
- Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP
- Ability to attend training and apply learning on routine operation, maintenance, and theory or laboratory instrumentation, SOPs, and regulatory guidelines
- Ability to use Excel, Word, and other Office systems
- Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy
- Ability to peer review data to ensure data is well organized with complete documentation
- Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions
- Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use
- Ability to apply applicable regulatory authority and guidelines with training
- Demonstrates theoretical understanding of the work tasks assigned
- Data archiving and maintenance
- Ability to maintain lab equipment
- Ability to operate within a clean room environment as needed
- Behavioral Requirements:
- Ability to see and hear, read, and write clear English
- Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing
- 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 with ability to work effectively under high pressure with multiple deadlines
- Strong ability to multi-task in a fast-paced environment
- Positive attitude and ability to work with others
- Ability to process a large volume of work
- Ability to effectively carry out and implement change
- Ability to put aside personal opinions and focus on business needs, department needs, or group needs
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.
