Associate - QA Representative - Floor SupportEli Lilly • Concord, California, United States
Associate - QA Representative - Floor Support
Eli Lilly
- Concord, California, United States
- Concord, California, United States
Über
Formulation and Parenteral Manufacturing
Device Assembly and Packaging Manufacturing
Warehouse Logistics
Facility, Utility and Maintenance
Responsibilities include:
Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
Function as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design
Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
Actively participate in required design reviews and final design qualification activities
Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
Provide quality oversight for the verification and qualification of the manufacturing buildings, including review of test cases, test execution, discrepancy resolution, etc.
Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross‑functional support with focus on the Manufacturing areas
Support the site organization in building technical capability, for a diverse cross‑functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Support the definition and execution of inspection readiness activities including support of site self‑inspections in GQA
Lead project initiatives needed in support of the project and Quality function
Resolve or elevate any compliance issues to the project, site, and Quality Management
Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
Basic Requirements:
3+ years’ experience in Quality pharmaceutical manufacturing required
5+ years’ experience in within the pharmaceutical or regulated manufacturing industry
Bachelors or equivalent degree in a scientific field
Additional Skills/Preferences:
Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
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 Microsoft office products, Trackwise, etc.
Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
Ability to work 8-12 hour shifts onsite (not eligible for remote work)
Ability to work overtime as required
ASQ Certified
CSQA (Computer Systems Quality Assurance) experience
Previous experience with manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management
Previous experience with Manufacturing Execution Systems.
Previous use of KNEAT – or other electronic validation software
Previous technical writing experience
Technical aptitude and ability to train and mentor others
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.
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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Sprachkenntnisse
- English
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