Senior Representative, Quality Assurance ( M-F Day Shift )

BioSpace; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the biopharmaceutical industry is seeking a Senior Representative for Quality Assurance in Bloomington, Indiana, to ensure compliance with regulations and maintain quality systems. The role demands strong communication and analytical skills alongside relevant experience in quality assurance and regulatory guidance. The position offers a competitive salary, comprehensive benefits, and the opportunity to partake in meaningful work impacting patients' lives.

Benefits

Leading pay and annual performance bonus

Generous paid time off including 14 paid holidays

Health, Dental, and Vision Insurance effective day one

Guaranteed 8% 401K contribution

14 weeks paid parental leave

Tuition Assistance

Life & Disability Insurance

Qualifications

• 5-8 years of relevant experience required with Bachelor’s degree.
• Min of 2 years GxP experience in a regulated industry.
• Strong interpersonal skills with the ability to manage multiple priorities.

Responsibilities

• Support customer audits and manage audit response actions.
• Maintain facility licenses and registrations.
• Oversee quality system metrics and author SOPs.

Skills

Quality Compliance

Analytical Skills

Problem-Solving

Communication

Project Management

Education

STEM Bachelor’s degree

Tools

Excel

Word

TrackWise

ComplianceWire

Job description

Senior Representative, Quality Assurance ( M-F Day Shift )

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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.

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.

Relationships

Reports to Manager

Essential Functions

• Quality Compliance
• Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions
• Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors
• Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions while onsite
• Review and approve responses to audit findings
• Assists in maintaining facility licenses and registrations
• Organizes documentation and facilitates review in support of client regulatory submissions
• Monitors and assesses changes to regulatory guidance and compendial monographs
• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes
• Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations
• Owns, maintains, and reports out Quality Key Performance Indicators (KPIs) for area of expertise
• Maintains a sufficient understanding of the quality systems and operations
• Lead meetings with clients and team
• Readiness and Response: Oversight, approval and implementation for Inspection Playbook and other process improvement projects
• Readiness and Response: Manages site Subject Matter Experts (SME) and program, including Training content and delivery
• Readiness and Response: Responsible for critical client and regulatory audit outputs, including audit response review and management and SME follow Ups
• Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders
• Internal: Perform Risk Assessment on facility areas annually
• Internal: Create Audit Schedule, and adhere to audit schedule
  
  
  

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. Ability to operate within a clean room environment as needed. Walking and/or standing for up to 8 to 12 hours depending on assigned area. Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

Qualifications

• STEM Bachelor’s degree, highly preferred
• 5-8 years of relevant experience with Bachelor’s degree, required
• 8+ years of experience or demonstrated excellence in role with justification
• Min of 2 years GxP experience or other regulated industry
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies
• Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures
• Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects
• Must be able to read and understand English-written job instructions and safety requirements
• Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred
• A strong working knowledge of quality systems and processes, preferred
• Technical Requirements
• Ability to use Excel, Word, and other office systems
• Ability to learn and use quality management software such as TrackWise or ComplianceWire
• Ability to understand and independently apply CGMPs to everyday work
• Demonstrates understanding of the work tasks assigned
• Executes procedures of moderate complexity with high quality
• Intermediate understanding of pharmaceutical laboratory and/or production operations
• Capable of learning unfamiliar principles or techniques with training
• Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor
• Ability to problem solve and execute and monitor corrective actions
• Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions
• Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor
• Seeks best practices for daily work activities

• Behavioral Requirements
• Ability to see and hear and read and write clear English
• 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 and well organized with ability to work effectively under high pressure with multiple deadlines
• Ability to put aside personal opinions and focus on business needs, department needs or group needs
• Ability to transfer knowledge to others via training or mentoring
• Demonstrated ability to guide others thorough communication and learning
• Ability to make decisions which have moderate impact on immediate work unit

• Leadership Requirements
• Lead by example according to the Company's values and culture
• Builds on contacts and relationships with peers
• Take initiative for personal and professional development
• Takes initiative when necessary to address changes in scope and procedural errors
• Builds trust and respect for self and department
  
  
  

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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  Internet News

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