What are the responsibilities and job description for the Supervisor, QC Afternoons position at Novo Nordisk?

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 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 Catalent Madison Biologics facility. The QC team is comprised of the following groups :

Microbiology : The Microbiology program ensures the safety of pharmaceutical products by testing solution(s), excipient(s), and finished products for disease-causing microorganisms. The Microbiology Program provides evidence-based and scientifically proven approaches and procedures that ensure sterility, determine antimicrobial effectiveness, detect microbial contamination / bioburden, and analyze endotoxins of manufactured product. In addition, the Microbiology Team collaborates with support groups to validate the assay methods used in testing finished products.

Environmental Monitoring : The Environmental Monitoring (EM) Program 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. The EM program is part of an overall control strategy designed to ensure patient safety and incorporates facility design and maintenance, effective access controls, good cleaning procedures, validated sanitization, and disinfection procedures, reliable process controls, consistent sample collection and testing, an effective training program, and quality assurance of materials, facilities, and equipment.

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 perform their specific job functions.

The Position

Join Novo Nordisk as a Supervisor QC (Chemistry) where you will oversee all activities within the functional area, manage resources, ensure training adherence, report on KPIs, and drive continuous improvement initiatives. You will also maintain quality standards, project timelines, and completion of release Certificates of Analysis. If you are passionate about maintaining quality standards in a dynamic pharmaceutical environment, we invite you to apply and be an integral part of our team.

This is a 2nd shift position : Monday - Friday 3 : 00pm-11 : 30pm

Relationships

Reports to : Sr Manager, QC

Direct Reports : 2-12

Essential Functions

Responsible for all activities within functional area

Manage resources assigned to each functional area

Ensure employee training is executed according to defined training plans and maintain current training plans

Identify, maintain, and report functional KPIs to site management

Monitor and report project milestone completion and timing

Accountable for revenue reporting and billing

Drive continuous improvement through leading cross function teams to address process improvement, system improvement, new regulations / expectations, new business needs, training improvements, and KPI performance improvements

Maintain safe and healthy work environment by establishing and enforcing organization standards and adhering to legal regulations

Review and approve data and reports

Conduct performance reviews and engage in employee hiring process

Routinely participate in customer team meetings

Assist in customer audits and regulatory inspections

Provide technical assistance for personnel

Lead team members to improve and reinforce performance of others

Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly

Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development

Other duties as assigned

Release and In-Process

Accountable for daily operations to maintain Quality standards and project timelines, including execution of release and in-process testing, coordination with stakeholders, and communication with leadership

Accountable for collaboration with internal Catalent stakeholders to complete release and in-process analyses and reports, maintain effective and efficient processes, and ensure appropriate test directives are established and followed

Accountable for completion of release Certificates of Analysis

Accountable for oversight of contract testing laboratories

Accountable for Quality Control data review function for routine testing

Supports instrument onboarding and maintenance

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 condition controlled.

Qualifications

Education / Experience :

Bachelor's Degree in a STEM discipline required

2 years laboratory experience required

2 years GMP or other regulated industry required

0-1 years of management experience preferred

Must be able to read and understand English-written job instructions and safety requirements

Technical Requirements :

Excellent written and verbal communication skills with internal and external customers

Provides technical support to their direct reports

Ability to communicate complex technical information to non-technical audiences

Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution

Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines

Leads regulatory and client audits as a Subject Matter Expert

Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process

Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones

Well organized with ability to handle and direct multiple activities across departments simultaneously

Behavioral Requirements :

Shares own ideas in a compelling manner that gains commitment from others

Inspires and persuades others to voluntarily follow direction

Negotiates skilfully and professionally and persuades others to approach issues in the same manner

Wins concessions while building relationships or knowing when to yield to another's point of view. Teaches team the art of persuasion

Anticipates reactions and positions of others and plans accordingly. Mentors team to do the same

Takes a proactive approach to shape and influence internal and external executive stakeholder expectations

Serves as a liaison between different stakeholder groups across departments

Effectively aligns and influences the interests of multiple stakeholders (client programs and company) with different priorities to quickly drive complex decisions

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 pace 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

Leadership Requirements :

Uses comprehensive knowledge of applicable principles, concepts, and practices and / or techniques to lead projects within a department, group, or team in a single function or focus

Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline

Manages strategic or continuous improvement activities with the team, across teams within the department, or across multiple departments within the site. Coordinates with teams in other departments and across the business unit

Helps identify department objectives to align with site goals. Regularly communicates to team, department, and company about department priorities and how aligned

Makes implementation plans and assignments that allocate cross functional resources appropriately to complete objective and provide development opportunities

Anticipates challenges and opportunities and adjusts contingency plans for department initiatives and team's project

Identifies initiatives with relevant milestones and schedules to effectively manage the progress and performance of the team and own work developing metrics to monitor performance to goal

Establishes an effective, professional, and positive relationship with employees

Clarifies responsibilities and expectations and holds employees accountable

Participates in and conducts timely HR-related processes

Provides timely constructive feedback that is clear and direct

Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance

Uses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilities

Recognizes and reinforces developmental efforts, progress, and improvements

Collaboratively works with direct reports to set meaningful performance objectives

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.

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