Scientist, Quality Control (Microbiology) Days

BioSpace; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biotech company in Bloomington, Indiana is seeking an Associate Scientist to perform microbiology testing and maintain GMP compliance. This role includes valuable opportunities for growth and contributing to life-changing therapies. Ideal candidates will have relevant degrees and industry experience, ensuring a high-quality standard.

Benefits

14 paid holidays

Health, Dental, and Vision Insurance

401K contribution with matching options

Tuition Assistance

Qualifications

• 3-5 years of experience in a regulated industry, including 1 year GMP experience.
• Experience with micropipettes required.
• Ability to understand English-written job instructions and safety requirements.

Responsibilities

• Perform routine testing of microbiology process samples and finished products.
• Analyze and interpret results in written and oral format.
• Support preventative maintenance and maintain a GMP quality system.

Skills

General laboratory equipment experience

Attention to detail

Education

Bachelor’s degree in science

Master’s degree in science

Job description

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 positionsAll employees enjoy generous paid time off including14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 a variety of skills necessary for biotech company operations. The position will perform routine testing of microbiology 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.

Schedule: typical business hours.

Relationships

Reports to Supervisor.

Essential Functions

Independently executes and properly documents cGMP Quality Control testingIndependently operates basic and moderately complex cGMP Quality Control equipmentAssists in authoring technical documents such as SOPs and reportsCoordinates with Supervisor to prioritize and schedule activities to meet deadlinesSupports continuous process improvement initiativesSupports training of specific analytical techniquesPerforms self-review of analytical data for accuracy and consistency with SOPEnters data into Laboratory Information Management System (LIMS) or laboratory reportsPerforms general lab housekeeping in adherence to 5S standardsInitiates and assists with records in TrackWiseAccurately completes routine and preventive maintenance on basic to moderately complex equipmentActively participates in team meetings and/or training sessionsFollow all safety and environmental requirements in the performance of dutiesOther duties as assignedInvestigation 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-conformanceInterview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess the quality impactConduct investigational meetings with required team members, if applicableUtilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factorsWork with cross functional team members to develop appropriate CAPA actionsAuthor/draft investigation reports with minimal guidanceEnsure investigations, corrections and CAPAs are generated and closed out in a timely mannerIdentify and analyze trends arising from individual investigationsSupport and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanismsPresent Major or Critical Deviations to the Deviation Review Board (DRB) committeeFacilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trendsManage, conduct/coordinate, track, and follow-up of activities related to trend CAPAsCoordinate 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 science field with 3-5 years of experience, including 1 year GMP experience or regulated industry requiredMaster’s degree in science field with 0-2 years of experience required, including 1 year GMP experience regulated industry preferredPhD in science field with 0-2 years of experience, GMP experience preferred or other regulated industryGeneral laboratory equipment experience, including micropipettes requiredMust be able to read and understand English-written job instructions and safety requirementsPreferredExperience maintaining and troubleshooting Quality Control equipmentFamiliarity with clean room procedure, aseptic technique, and general lab equipment experiencecGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledgeExperience following standard operating procedures (SOP)

Technical RequirementsProficient at all technical requirements of an Associate Scientist ANDApplies technical understand and functional knowledge to conduct QC laboratory testing as requiredAble to perform investigations and deviations to determine root causes and implement corrective and preventive actionsAble to serve as a liaison and technical consultant/advisor to customers and clients, both internally and externallyMay act as a technical resource or subject matter expert within own work group/project teamActive participant in problem solving and competent at-risk mitigation

Behavioral RequirementsAbility 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, writingAbility 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 needs

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.