Lead, Inspection Fri-Sun WPM

BioSpace; Bloomington (IN); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Leading pay and annual performance bonus

Generous paid time off including 14 paid holidays

Health Insurance effective day one

Guaranteed 8% 401K contribution

Tuition Assistance

Job summary

A leading biopharmaceutical company in Bloomington, Indiana, seeks a Lead, Inspection role. The candidate will be responsible for coordinating manufacturing tasks and leading investigations of procedural deviations. Required qualifications include a high school diploma/GED and 2 years of pharmaceutical manufacturing experience. This role involves weekend shifts, offering a competitive salary and benefits including health insurance and generous paid time off.

Qualifications

• 2 years of direct pharmaceutical manufacturing experience required.
• 2 years of GMP experience preferred.
• Understanding of CGMPs and ability to interpret data.

Responsibilities

• Lead and coordinate the work of others within established procedures.
• Assist manufacturing personnel to identify and eliminate waste.
• Take a leadership role in investigations of procedural deviations.

Skills

Proficient in Excel

Proficient in Word

Ability to learn TrackWise

Ability to learn ComplianceWire

Education

High School/GED

Associate’s degree or higher preferred

Tools

TrackWise

LIMS

JD Edwards

Job description

Overview

Lead, Inspection Fri-Sun WPM role 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

The Position

Shift: WPM Friday - Sunday 6PM-7:30AM. This initial shift may change in the future due to business needs; candidates must be flexible for shift changes, including weekends.

Relationships: Reports to Manufacturing Supervisor.

Essential Functions

• Lead and coordinate the work of others within established procedures; typically not a people manager.
• Assist manufacturing personnel to identify and eliminate waste, implement standard-work, and provide problem solving and solution implementation assistance.
• Take a leadership role in investigations of procedural deviations, SOP revisions and non-conformances, collaborating with Quality Assurance to develop and execute CAPAs.
• May lead shift handover or act as shift lead in the absence of a supervisor.
• Apply Operational Excellence concepts and tools; assign daily tasks; manage operator rotations; escalate non-conformances to Supervisor.
• Maintain advanced documentation skills (GMP preferred) and work autonomously in a high-stress environment; collaborate with cross-functional departments.
• Identify opportunities for improvement (e.g., 5S, waste elimination, non-value-added tasks); lead and perform first-line operator functions.
• Review activity within the Master Batch Record (MBR) to ensure accurate communication of production activities per procedures and ALCOA principles.
• Operate equipment safely per cGMPs; troubleshoot basic equipment; perform setup/changeover for production equipment; escalate issues to avoid downtime.
• Provide training on department equipment and print/diagnose reports; submit maintenance work orders; assist in staffing and shift reports; support deviations investigations and training as needed.

Physical Requirements

Frequent sitting, standing, walking, reading, computer use; occasional stooping, kneeling, bending; frequent lifting up to 10 pounds and occasional up to 35 pounds. Must pass annual vision test. Must comply with EHS responsibilities. Clean room environment as needed.

Qualifications

• High School/GED required
• Associate’s degree or higher preferred
• 2 years of direct pharmaceutical manufacturing experience
• 2 years of GMP experience
• Technical requirements: Proficient in Excel, Word; able to learn TrackWise, ComplianceWire, JD Edwards, LIMS, etc.
• Understanding and application of CGMPs; ability to interpret data, analyze trends, and participate in solutions; contribute to deviation investigations and corrective/preventive actions.

Behavioral Requirements

• Effective communication and ability to follow detailed instructions; work well under pressure and meet deadlines
• Time management and ability to work independently or in a team
• Detail-oriented, organized, and focused on business and department needs

Equality and Accommodation

We commit to an inclusive recruitment process and equality of opportunity for all job applicants. Novo Nordisk is an equal opportunity employer. If you need special assistance or an accommodation to apply, please call 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about application status.