Senior Associate
6 hours ago
At 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 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.
The Sr. Associate - QA for Quality Control Labs provides support to all quality activities in Kinsale Quality Control Labs. The Sr. Associate QA’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
Key Objectives/Deliverables:
1. Provides Quality leadership, direction and governance for the specific area of responsibility.
2. Manages quality-related matters specific to area (Quality System or Quality Program) of responsibility.
3. Is responsible for approving appropriate quality-related documents. An approval signature confirms that Lilly and GMP requirements have been met.
4. Performs ongoing monitoring that includes:
1. monitoring of quality systems,
2. the self-inspection program,
3. verification of the effective implementation of key GMP programs,
4. review of systems that impact product and data quality to ensure that they operate in a state of control,
5. establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
Key Responsibilities:
1. Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
2. Establishment, maintenance and management of a control system for the specific Quality System(s)/Program.
3. Assurance that the Quality System(s)/Program remains in a validated state and within regulatory commitments.
4. Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality System(s)/Program.
5. Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
6. Assess the impact on product and data quality of events associated with the area(s) of responsibility.
7. Review and approve laboratory analytical investigations, deviation investigations, change controls, and ensure that all appropriate records are documented and retrievable.
8. Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
9. Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic quality reviews.
10. Review and approval of other key GMP documents such as GMP standard operating procedures, specifications, as appropriate to area of responsibility.
11. Audit and participation in the Site Self-Inspection program and Time on the Floor Audits of the area(s) of responsibility for compliance with the Product Quality System, QA Policy and Technical Guidelines and Corp. and local procedures.
12. Participate in regulatory inspection preparations.
13. Participate in APR activities.
14. Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in area of responsibility.
15. Evaluation and approval of 3rd party vendors/contractors/service providers as appropriate for area of responsibility.
16. Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.
17. Contribution to the Quality (GMP) Plan for specific Quality System/Program Initiatives.
18. Owner of several general SOPs relating to area of responsibility.
19. Perform annual QA GDP review of GMP Laboratory Notebooks.
20. Provide back-up cover for other QCL QA Reps.
Basic Requirements:
1. BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
2. Previous GMP laboratory knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
Additional Preferences:
1. Experience in quality support for Quality Control activities.
2. Thorough technical understanding of quality systems and regulatory requirements.
3. Knowledge of pharmaceutical manufacturing operations.
4. Demonstrated coaching and mentoring skills.
5. Experience in root cause analysis and analytical investigations.
6. Demonstrated strong written and verbal communications skills.
7. Strong attention to detail.
8. Proficiency with computer system applications.
9. Excellent interpersonal skills and networking skills.
10. Ability to organize and prioritize multiple tasks.
11. Ability to influence diverse groups and manage relationships.
Other Information:
1. Must complete required training for Quality Assurance Associate.
2. No certifications required.
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