Quality Assurance Operations Specialist (Night Shift)
Eli Lilly and Company
2 months ago
On-site
Pleasant Prairie, WI
Operations
Responsibilities:
- Provide QA oversight to GMP operations on the assigned night shift; ensure GMP compliance and inspection readiness.
- Maintain a safe work environment and support Health, Safety, and Environmental corporate and site goals.
- Follow good documentation practices and site procedures.
- Lead, mentor, and coach operations and support personnel on quality matters.
- Ensure regular presence in operational areas to monitor GMP programs and quality systems.
- Assess and triage deviations within the local process team; support issue resolution and escalation to site-based process teams.
- Resolve or provide advice on product-related issues with internal support groups and external partners.
- Participate in self-led inspections and support regulatory inspections.
- Initiate, review, and approve quality documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents).
- Participate in continuous improvement projects to improve productivity.
- Approve commissioning, qualification, and validation documents for computer systems and equipment.
- Network with Global Parenteral Network sites to benchmark and replicate best practices.
Basic Requirements:
- Bachelor’s degree in science, engineering, or pharmaceutical-related field.
- Minimum 3 years in the pharmaceutical industry with specific batch disposition experience.
- On-site presence required.
- Work authorization required in the U.S. (company will not sponsor visas).
Additional Skills/Preferences:
- Demonstrated understanding of cGMP and experience in GMP production environments.
- Experience with C&Q and validation oversight, including automation and computer systems validation.
- Knowledge of US/EU/Japan and other pharmaceutical manufacturing regulations.
- Proficiency with applicable computer systems and Manufacturing Execution Systems.
- Experience with CSQA and electronic validation software (e.g., KNEAT).
- Strong communication and technical writing skills.
- Ability to perform root cause analysis/troubleshooting.
- ASQ certification.
Schedule/Other:
- Primary location: Kenosha County, WI.
- Work 12-hour shifts (1800–0600) onsite on a rotating 2-2-3 (or similar) schedule; overtime/off-shift support may be required; travel ~10%.
Benefits:
- Eligibility for a company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance/death benefits; certain time off/leave of absence; well-being benefits (e.g., EAP, fitness, employee clubs/activities).
- Company bonus eligibility for full-time equivalent employees.
Work authorization/application instruction (as stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Provide QA oversight to GMP operations on the assigned night shift; ensure GMP compliance and inspection readiness.
- Maintain a safe work environment and support Health, Safety, and Environmental corporate and site goals.
- Follow good documentation practices and site procedures.
- Lead, mentor, and coach operations and support personnel on quality matters.
- Ensure regular presence in operational areas to monitor GMP programs and quality systems.
- Assess and triage deviations within the local process team; support issue resolution and escalation to site-based process teams.
- Resolve or provide advice on product-related issues with internal support groups and external partners.
- Participate in self-led inspections and support regulatory inspections.
- Initiate, review, and approve quality documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents).
- Participate in continuous improvement projects to improve productivity.
- Approve commissioning, qualification, and validation documents for computer systems and equipment.
- Network with Global Parenteral Network sites to benchmark and replicate best practices.
Basic Requirements:
- Bachelor’s degree in science, engineering, or pharmaceutical-related field.
- Minimum 3 years in the pharmaceutical industry with specific batch disposition experience.
- On-site presence required.
- Work authorization required in the U.S. (company will not sponsor visas).
Additional Skills/Preferences:
- Demonstrated understanding of cGMP and experience in GMP production environments.
- Experience with C&Q and validation oversight, including automation and computer systems validation.
- Knowledge of US/EU/Japan and other pharmaceutical manufacturing regulations.
- Proficiency with applicable computer systems and Manufacturing Execution Systems.
- Experience with CSQA and electronic validation software (e.g., KNEAT).
- Strong communication and technical writing skills.
- Ability to perform root cause analysis/troubleshooting.
- ASQ certification.
Schedule/Other:
- Primary location: Kenosha County, WI.
- Work 12-hour shifts (1800–0600) onsite on a rotating 2-2-3 (or similar) schedule; overtime/off-shift support may be required; travel ~10%.
Benefits:
- Eligibility for a company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance/death benefits; certain time off/leave of absence; well-being benefits (e.g., EAP, fitness, employee clubs/activities).
- Company bonus eligibility for full-time equivalent employees.
Work authorization/application instruction (as stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation