Quality Assurance Process Team Device Assembly and Packaging

BioSpace; Concord (NC); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Time off and leave

Job summary

Lilly is seeking a Quality Assurance Process team member to lead quality oversight in manufacturing areas such as Device Assembly, Packaging, and Project Focus for DAP. You will mentor operations staff, review deviations, change controls, and ensure testing and qualification activities meet quality standards.

Join a global team committed to patient well-being; candidates should have a Bachelor's in a scientific field, 4+ years in pharmaceutical QA, and experience with GxP, C&Q, and computer

Qualifications

• Bachelor's degree in a scientific field is required.
• 4+ years of experience in quality pharmaceutical manufacturing.
• Experience with C&Q, verification and validation, including automation and computer systems validation.
• Must be legally authorized to work in the United States.

Responsibilities

• Lead, mentor, and coach operations on quality matters.
• Provide support on deviations, change controls, and procedure updates.
• Oversee verification and qualification of equipment, buildings, and computer systems.
• Monitor and ensure compliance to quality standards in operations.
• Develop and manage the annual quality floor time plan.
• Identify and implement continuous improvements.

Skills

Quality assurance

GxP compliance

Process validation

Deviation management

Education

Bachelor's degree in a scientific field

Tools

SAP

TrackWise

MES

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

The Quality Assurance Process team member is responsible for demonstrating leadership, teamwork, and quality knowledge on a day to day basis. They are responsible to lead, mentor, and coach operations and support personnel on quality matters. They will provide support on deviations, change controls, procedure updates, commissioning, and qualification activities. This role will have a regular presence in the operational areas to monitor and confirm execution according to quality standards.

This role will participate on the local process team for one of following manufacturing areas:

• Device Assembly
• Packaging
• Project Focus for DAP

Responsibilities Include

• Active presence in operational areas
• Provide quality oversight for the verification and qualification of the manufacturing equipment, buildings, including review of test cases, test execution, discrepancy resolution, etc.
• Provides guidance for leveling, resolving, reviewing and approving deviations and change controls
• Demonstrate a comprehensive understanding of the process and its associated equipment, facilities, computer systems and operations
• Lead and establish annual quality floor time plan
• Support resolution of batch documentation such as alarm response, exceptions, etc
• Support asset qualification monitoring reviews and reports
• Required to respond to operational issues outside of core business hours / days.
• Attend and provide update on quality at daily process team meeting
• Support the site organization in building technical capability, in Quality, the project team, and area process teams, including mentoring and training of new Quality staff
• Resolve or elevate any compliance issues to Quality Management
• Identify and implement continuous improvements
• Measure, maintain, and achieve quality metrics
• Serve as positive role models for their Process Team peers and for the organization in general

Basic Requirements

• Bachelors degree in a scientific field
• 4+ years’ experience in Quality pharmaceutical manufacturing required
• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

Additional Skills/Preferences

• ASQ Certified
• CSQA experience
• Previous experience with device assembly or packaging,
• Previous experience with Manufacturing Execution Systems.
• Previous use of KNEAT – or other electronic validation software
• Previous technical writing experience
• Use process knowledge and control strategy to make quality decisions
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Ability to work independently as a Quality SME with minimal supervision
• Proficiency with computer systems including SAP, Trackwise, MES etc.
• Responsible for maintaining a safe work environment,
• Ability to work 8 hour shifts onsite (not eligible for remote work)
• Ability to work overtime as required

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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
• 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.

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