Associate-Quality Assurance

Location Type: Not Specified

 

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$51,000 – $141,900

The Associate-Quality Assurance will have primary responsibility for Quality systems management within the QA Compliance area. This includes complying with Good Manufacturing Practices (GMPs) and Global Lilly Standards (GQS), Monitoring of quality systems, not limited to: revisions to the Lilly Standards, Quality Plan, and Activity Planning.

Main Responsibilities:

• Maintain the Standard Operation Procedure (SOP) system and review the training of the Quality Assurance (QA), Quality Integrated Services (QIS) & Quality Control Laboratories (QCL) departments.
• Approval of stability protocols generated and annual evaluations.
• Investigations of consumer and affiliate complaints.
• Work on document approvals in LIMS.
• Perform additional tasks identified by supervision.
• Carry out the evaluation of the documentation of the batch of materials to determine if it satisfactorily meets the regulatory requirements for its disposition. Batch/ API/ Materials approval process.
• Ensure that analytical results meet material specifications. Approve the batches and send the documentation after approval to the GMP Library in PR01 following the appropriate procedures.
• Generate Certificates of Analysis (COA) for the batches as required.
• Generate records in the TW1000 “Activity Planning” module (Lilly Std gap assessments, regulatory inspections, etc.)
• Investigate, assess the impact and document customer complaints. Lead Compliant Boards, when needed. Promptly address complaints that involve reporting to regulatory agencies. Monitor and identify trends and act proactively to implement corrective actions.
• Support Deviation and Change Control Boards coordination and leading, when needed.
• Comply with cGMP’s, GDPs and Global Standards
• Monitoring of Lilly Standards, Quality Plans, Activity planning
• Participate in Self Inspection Program ensuring associated actions were generated.
• Compliance cGMP activities/ Monitor and Ensure Compliance: Oversee the implementation and adherence to GMP regulations and guidelines across Quality Compliance.
• Maintain accurate and thorough records of all compliance-related activities, audits, and inspections.
• Develop and conduct training programs for employees on GMP regulations and best practices.
• Audit Preparation and Execution: Participate during internal and external audits, conduct audits, and ensure that findings are addressed promptly. Support Inspection readiness activities, when needed.
• Risk Management: Identify potential compliance risks and support develop strategies to mitigate them.
• Assist in the creation and updating of GMP policies and procedures, as needed.
• Provide/support training creation as SME from a compliance standpoint.
• Comply with records retention and proper record maintenance requirements.

Basic Requirements:

• Bachelor’s degree or higher in sciences or engineering
• 3-5 years of experience in cGMP/QA Compliance environment. Salary commensurate with experience.
• Comprehensive understanding of cGMP regulations, quality control processes, and industry standards.
• Experience managing complaints, deviations, change controls, batch disposition, batch record review, among others.
• Experience interacting with regulators and inspectors.
• Bilingual (English and Spanish) is required

Additional Preferences:

• Understanding and working knowledge of inspection readiness, QA Compliance area, technical writing, as applicable.
• Working knowledge of laboratory, operations, and stability areas.
• Ability to work on multiple concurrent initiatives according to area needs.
• Strong compliance and sound judgement
• Self-starter and reliable
• Ability to connect with others at all levels of the organization and at corporate level
• Teamwork oriented
• Attention to details, analytical thinking, and problem-solving skills
• Availability to support a 24/7 operation, if needed

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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 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 employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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