Organization Overview:Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss!
Job Responsibilities:The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production.
- Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems
- Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner
- Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls)
- Additional job duties as required
Basic Requirements:- Bachelor's degree in STEM
- Experience working in the pharmaceutical or medical device industry in QA roles
- Previous batch disposition experience
- Ability to make technical decisions, provide guidance to the site
- Proficiency with applicable computer systems
- Demonstrated strong oral and written communication skills
- Demonstrated interpersonal skills and the ability to work as a team
- Root cause analysis/troubleshooting skills
- Demonstrated attention to detail and ability to maintain quality systems
- Previous regulatory inspection readiness and inspection execution experience
- Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- 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 R1-R4.
Additional Skills/Preferences:- Ability to work 8-hour days - Wednesday through Sunday Day Shift (not eligible for remote work)
- Ability to work overtime and be on-call as required
- Proven ability to work independently or as part of a Team to resolve an issue
- Previous experience with Event and Change Management process
- Proficiency with SAP, MES, and Trackwise
- Previous experience with device and parenteral product materials
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). 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.
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