Quality Assurance Associate
2 days ago
We're seeking a highly skilled Quality Assurance Associate to join our team at Lilly. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our small molecule manufacturing operations.
Key Responsibilities:- Provide quality oversight of small molecule manufacturing operations, focusing on holistic review of key activities associated with or impacting the manufacturing processes.
- Serve as the initial point of contact for all quality-related issues.
- Coordinate and perform QA responsibilities of API manufacturing (small molecules).
- Review and approve documents, including procedures, master production records, change controls, deviations, equipment qualifications, analytical methods, process validations, and computerized system validations.
- Provide technical support for deviation investigations, including root cause analysis, countermeasure development, and implementation of actions.
- Assess the impact of change controls and events on the product and regulatory commitments.
- Ensure all processes are in an appropriate state of control.
- Evaluate and ensure compliance with regulatory requirements and industry standards.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Participate in regulatory inspection preparations and provide support during inspections.
- Bachelor's Degree in a relevant field, such as Engineering, Chemistry, Biology, or a science-related degree.
- 5+ years of experience in a pharmaceutical manufacturing environment, preferably in quality assurance or a related field.
- Knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering, preferred.
- Strong technical understanding of quality systems and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
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.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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