Engineer-QA Compliance Professional
Branchburg Township, New Jersey
Company OverviewAt 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 39,000 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. #WeAreLilly
ResponsibilitiesThe Quality Professional works within Lilly cross-functional groups, anticipates and resolves problems while driving solutions for processes and/or products. May lead small to large projects or programs with moderate risk. Manages quality-related matters specific to area of responsibility. Provides assistance to cross-functional groups with troubleshooting investigations and problem resolution. Assists with the implementation of change controls and/or reviews and approves GMP documents associated within area of responsibility. Ensures regulatory compliance and procedural consistency within GMP areas: laboratory, manufacturing, utilities, and automation. Ensures area of responsibility remains inspection ready and may provide assistance during regulatory/GMP inspections. Ensures observations associated with Lilly Branchburg are adequately addressed and completed on schedule. Represents Quality per Manufacturing Standard for Operational Excellence (MSOE) 602 within area of responsibility. Requires approximately 5% travel.
Perform day-to-day activities including (based on area of responsibility):
- Evaluate and process observations, trends or deviations to determine root cause(s) and assess quality impact. Recommend CAPA’s and ensure CAPAs implemented are effective.
- Performs risk assessments associated with materials and suppler quality.
- Creates/maintains quality agreements.
- Ensures harmonization of raw material specifications across applicable API sites
- Writes supplier performance evaluations
- Evaluate change controls and associated risk assessments.
- Ensure sustainable compliance to all regulations related to area of oversight (e.g. 21 CFR Part 11 related to computer systems etc).
- Review/approve SOP’s, Reports, Equipment/Method Qualifications/Verifications/Validations, Excursions, specifications and Work Orders for compliance to regulatory standards.
- Review/approve executed batch tickets and participate in API bulk release activities.
- Review/approve raw material specification packages, support material management at Branchburg site
- Assist in creating quality metrics. Keep Quality Management informed of compliance issues.
- Assist with activities associated with technology transfers or product launches to and from Lilly Branchburg facilities.
- Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing,
- Laboratories, Maintenance.Validation or supporting business units.
- Ensure compliance with applicable Lilly global standards and regulatory guidelines.
- May serve as core member on Process Team(s), continuous improvement, and general site support.
- Participate in Regulatory and partner inspections as necessary. Ensure timely follow up to any inspection findings.
- Bachelors degree in the sciences with a minimum of 2 years of experience preferred in the Biopharmaceutical industry.
- Previous technical experience in supplier quality and material qualification required.
- Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
- Possesses a conceptual understanding of all Quality functions and business areas.
- Must have the ability to function in a fast-paced environment and communicate effectively with management.
- Must be able to work in a cross-functional environment
- Must be proficient in Microsoft applications.
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 57384.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our scientists and researchers are developing the breakthrough medicines of tomorrow. Join us and become a creative innovator and thinker who can improve the lives of millions.
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