QA Floor Support Supervisor (Night Shift) - Device Assembly & Packaging

BioSpace; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading healthcare company is seeking a QA Floor Support Supervisor for the night shift in Device Assembly & Packaging. This role involves overseeing quality assurance operations, leading a team, and ensuring compliance with GMP standards. Candidates should have significant experience in pharmaceutical operations and strong leadership skills.

Benefits

Competitive wages

Bonuses

Health insurance

401(k)

Paid time off

Well-being programs

Qualifications

• At least 5 years supporting pharmaceutical operations.
• Strong communication, decision-making, and problem-solving skills.
• Knowledge of manufacturing processes and Quality Systems.

Responsibilities

• Lead a team of 6-10 Quality Specialists.
• Ensure compliance with good documentation practices.
• Monitor GMP programs during night shifts.

Skills

Communication

Decision-making

Problem-solving

Attention to detail

Education

High School Diploma or equivalent

Bachelor’s degree in a relevant field

Tools

SAP

TrackWise

GMARS

Job description

QA Floor Support Supervisor (Night Shift) - Device Assembly & Packaging

Join us to apply for the QA Floor Support Supervisor (Night Shift) - Device Assembly & Packaging role at BioSpace.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and contribute to our communities through philanthropy and volunteerism. We are committed to putting people first and making a difference.

The Quality Assurance Floor Supervisor is responsible for leading a team of QA Specialists, reporting directly to the Associate Director – DAP and Warehouse Quality. This role provides support and QA oversight for night shift GMP operations in the Device Assembly and Packaging (DAP) area. The supervisor collaborates with team members to support multiple production functions, ensuring quality and compliance.

Key Objectives/Deliverables

• Ensure safety compliance and maintain a safe work environment supporting HSE goals.
• Manage a team of 6-10 Quality Specialists.
• Ensure team training is completed and up-to-date.
• Communicate with day shift QA support and escalate issues when necessary.
• Maintain compliance with good documentation practices and procedures.
• Lead, mentor, and coach team members to foster a quality culture.
• Monitor GMP programs and quality systems during night shifts in device assembly and packaging areas.
• Assess and triage deviations and observations within GMP areas.
• Review and approve GMP documentation supporting daily operations.
• Provide QA system support and troubleshoot issues in systems like SAP, TrackWise, GMARS.
• Participate in inspections and support regulatory reviews.
• Review and ensure quality attributes are met across documentation and procedures.
• Work collaboratively across functions and organizational levels.

Basic Requirements

• High School Diploma or equivalent.
• At least 5 years supporting pharmaceutical operations.

Additional Preferences

• Ability to work night shifts.
• Bachelor’s degree in a relevant field preferred.
• Strong communication, decision-making, and problem-solving skills.
• Knowledge of manufacturing processes and Quality Systems.
• Proficiency with inventory and deviations management systems.
• Attention to detail and ability to work independently or in teams.
• Willingness to work overtime and occasional first shifts or short-term assignments.

Other Information

• Position involves a 12-hour night shift schedule, with transition from day shift during onboarding.
• May require responding to operational issues outside regular hours.
• Occasional overtime and mobility within facilities may be required.

Lilly is committed to diversity and inclusion. If accommodations are needed during the application process, please complete the workplace accommodation request form.

We are an Equal Opportunity Employer, and our benefits include competitive wages, bonuses, health insurance, 401(k), paid time off, and various well-being programs. Actual compensation depends on experience and location, with an estimated range of $35.33 - $58.89 per hour.