Supervisor - Quality Assurance Floor Support (Day Shift)

BioSpace; Durham (NC); On-site; USD 35,000 - 58,000; Full time

Job summary

An established industry player in healthcare seeks a Quality Assurance Supervisor to lead a dedicated team. This role involves overseeing GMP operations, ensuring compliance, and fostering a culture of quality. You will mentor and coach specialists, manage documentation, and engage in continuous improvement initiatives. If you are passionate about making a difference in people's lives and excel in a dynamic environment, this opportunity is perfect for you. Join a team that values innovation and commitment to quality in delivering life-changing medicines.

Benefits

401(k)

Medical Benefits

Dental Benefits

Vision Benefits

Vacation Benefits

Life Insurance

Fitness Benefits

Employee Assistance Program

Qualifications

• 5 years experience in quality role supporting parenteral manufacturing.
• Strong knowledge of GMP and quality systems.

Responsibilities

• Lead and mentor a team of Quality Specialists.
• Ensure compliance with good documentation practices.
• Monitor GMP programs and quality systems.

Skills

Quality Assurance

Documentation Practices

Aseptic Practices

Problem-Solving Skills

Communication Skills

Education

High School Diploma

Bachelor’s Degree in Science or Engineering

Tools

SAP

Trackwise

PMX

SmartLab

GMARS

Job description

Supervisor - Quality Assurance Floor Support (Day Shift)

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Supervisor - Quality Assurance Floor Support (Day Shift)

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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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Quality Assurance Floor Support supervisor is responsible for providing leadership to a team of QA Specialists, while reporting directly to the Associate Director – QA Parenteral. The Quality Assurance Floor Support Supervisor provides support and QA oversight to GMP operations in the formulation, filling and visual inspection process areas. The QA Floor Support Supervisor works along with their team members supporting multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensure compliance.

Responsibilities

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
• Responsible for managing 6-10 Quality Specialists supporting parenteral operations with the specialist working across multiple shifts.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
• Lead, mentor, and coach Quality Specialists, Operations, and support personnel on quality matters, such as aseptic practices, while driving the site Quality culture.
• Ensures regular presence in preparation, formulation, filling and visual inspection areas to monitor GMP programs, and quality systems.
• Lead, mentor, and coach Quality Specialists, Operations, and support personnel on quality matters, such as aseptic practices, continuous improvement, while driving the site Quality culture.
• Responsible for ensuring team is trained and training remains in compliance.
• Ability to assess, create, and triage deviations / observations that occur within the parenteral areas.
• Reviews and approves GMP documentation in support of daily operations such as: Maintenance Action Plans, Return to Service and Release of equipment, product, and area holds, spare parts consultation, work order assessments and issue resolution, and other documentation as required.
• Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, and other systems as required.)
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Review and / or redline to GMP documents ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, etc.).
• Communicates with Associate Director and Quality Representatives on quality and operational issues.
• Work cross functionally and collaboratively with all levels of the organization.
  
  
  

Basic Requirements

• High School Diploma or equivalent
• 5 years experience in quality role supporting parenteral manufacturing operations
  
  
  

Additional Skills/Preferences

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Demonstrated strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
• Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.
  
  
  

Additional Information

• Position is first shift, Monday - Friday, with first shift training required for a period of 2 – 4 months.
• May be required to respond to operational issues outside of core business hours / days.
• Ability to work overtime, as requested
• Applicant may work in various areas within Parenteral Building. Mobility requirements should be considered when applying for this position.
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$35.33 - $58.89

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

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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