What are the responsibilities and job description for the Quality Control Scientist - Weekend Night Shift 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 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
The working hours for this position will be Friday, Saturday & Sunday from 6pm-6:30am.
The position will perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and oral format. Additionally, this position will support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, and contributions to process improvement initiatives.
Relationships
Reports to Supervisor.
Essential Functions
Independently executes and properly documents cGMP Quality Control testing
Independently operates basic and moderately complex cGMP Quality Control equipment
Assists in authoring technical documents such as SOPs and reports
Coordinates with Supervisor to prioritize and schedule activities to meet deadlines
Supports continuous process improvement initiatives
Supports training of specific analytical techniques
Performs self-review of analytical data for accuracy and consistency with SOP
Enters data into Laboratory Information Management System (LIMS) or laboratory reports
Performs general lab housekeeping in adherence to 5S standards
Initiates and assists with records in TrackWise
Accurately completes routine and preventive maintenance on basic to moderately complex equipment
Actively participates in team meetings and/or training sessions
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned
Investigation TeamEnsure timely completion of investigations through the following activities in Trackwise to include but not limited toCoordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance
Interview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess the quality impact
Conduct investigational meetings with required team members, if applicable
Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors
Work with cross functional team members to develop appropriate CAPA actions
Author/draft investigation reports with minimal guidance
Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner
Identify and analyze trends arising from individual investigations
Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms
Present Major or Critical Deviations to the Deviation Review Board (DRB) committee
Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends
Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPAs
Coordinate the review of tr5end CAPAs to the assigned departments and determine their effectiveness
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. 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
Bachelor’s degree in Chemistry/Biochemistry, Analytical Chemistry or related Chemistry field with at least 3 years of experience, including 1 year GMP experience or regulated industry, required OR
Master’s degree in science field with up to 2 years of experience, including 1 year GMP experience regulated industry, required OR
PhD in science field with 0 years of experience, GMP experience preferred or other regulated industry, required.
General laboratory equipment experience, including micropipette is required. Experience with pH meter, Scales, Spectrophotometer, HPLC, and related instruments is strongly preferred.
Wet Chemistry lab experience including pH. Density, Osmolarity, moisture etc; protein assay; and low/medium complexity of HPLC testing experiences is strongly preferred
Must be able to read and understand English-written job instructions and safety requirements
PreferredStrong understanding of analytical chemistry and simple and moderately complex lab equipment
Experience maintaining and troubleshooting Quality Control equipment
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)Technical RequirementsProficient at all technical requirements of an Associate Scientist AND
Applies technical understand and functional knowledge to conduct QC laboratory testing as required
Able to perform investigations and deviations to determine root causes and implement corrective and preventive actions
Able to serve as a liaison and technical consultant/advisor to customers and clients, both internally and externally
May act as a technical resource or subject matter expert within own work group/project team
Active participant in problem solving and competent at-risk mitigation
Behavioral RequirementsAbility 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
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.
The Position
The working hours for this position will be Friday, Saturday & Sunday from 6pm-6:30am.
The position will perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and oral format. Additionally, this position will support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, and contributions to process improvement initiatives.
Relationships
Reports to Supervisor.
Essential Functions
Independently executes and properly documents cGMP Quality Control testing
Independently operates basic and moderately complex cGMP Quality Control equipment
Assists in authoring technical documents such as SOPs and reports
Coordinates with Supervisor to prioritize and schedule activities to meet deadlines
Supports continuous process improvement initiatives
Supports training of specific analytical techniques
Performs self-review of analytical data for accuracy and consistency with SOP
Enters data into Laboratory Information Management System (LIMS) or laboratory reports
Performs general lab housekeeping in adherence to 5S standards
Initiates and assists with records in TrackWise
Accurately completes routine and preventive maintenance on basic to moderately complex equipment
Actively participates in team meetings and/or training sessions
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned
Investigation TeamEnsure timely completion of investigations through the following activities in Trackwise to include but not limited toCoordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance
Interview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess the quality impact
Conduct investigational meetings with required team members, if applicable
Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors
Work with cross functional team members to develop appropriate CAPA actions
Author/draft investigation reports with minimal guidance
Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner
Identify and analyze trends arising from individual investigations
Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms
Present Major or Critical Deviations to the Deviation Review Board (DRB) committee
Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends
Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPAs
Coordinate the review of tr5end CAPAs to the assigned departments and determine their effectiveness
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. 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
Bachelor’s degree in Chemistry/Biochemistry, Analytical Chemistry or related Chemistry field with at least 3 years of experience, including 1 year GMP experience or regulated industry, required OR
Master’s degree in science field with up to 2 years of experience, including 1 year GMP experience regulated industry, required OR
PhD in science field with 0 years of experience, GMP experience preferred or other regulated industry, required.
General laboratory equipment experience, including micropipette is required. Experience with pH meter, Scales, Spectrophotometer, HPLC, and related instruments is strongly preferred.
Wet Chemistry lab experience including pH. Density, Osmolarity, moisture etc; protein assay; and low/medium complexity of HPLC testing experiences is strongly preferred
Must be able to read and understand English-written job instructions and safety requirements
PreferredStrong understanding of analytical chemistry and simple and moderately complex lab equipment
Experience maintaining and troubleshooting Quality Control equipment
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)Technical RequirementsProficient at all technical requirements of an Associate Scientist AND
Applies technical understand and functional knowledge to conduct QC laboratory testing as required
Able to perform investigations and deviations to determine root causes and implement corrective and preventive actions
Able to serve as a liaison and technical consultant/advisor to customers and clients, both internally and externally
May act as a technical resource or subject matter expert within own work group/project team
Active participant in problem solving and competent at-risk mitigation
Behavioral RequirementsAbility 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
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.
Night Auditor
Quality Inn and Suites -
Bedford, IN
