Representative - QA - IAPI (R2-R3)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 72,000 - 101,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation

Medical/Dental/Vision

Flexible Spending

Life Insurance

Well-being programs

Job summary

Lilly in Indianapolis is seeking a Representative - QA - IAPI (R2-R3) to provide quality support across API operations and ensure GMP compliance. The role involves reviewing GMP docs, deviation/change management, data review, and readiness for inspections; requires a Bachelor's in a scientific field and 2 years' cGMP experience; 24-hour operations support.

Part-time telecommuting may be permitted. Compensation ranges from $71,531 to $101,275 per year with benefits including 401(k), pension, and

Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related field; 2 years with cGMPs and quality systems.
• 2 years' experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs; 1 year of statistics; Deviation and Change Management; Inspection Readiness.
• Must support 24 hour/day operations; Part-time telecommuting may be permitted.

Responsibilities

• Provide quality support to Indianapolis API Operations manufacturing and laboratory areas and ensure robust quality systems and GMP compliance.
• Review and approve key GMP documentation; contribute to deviation investigations and change control proposals; provide quality guidance across functions.
• Maintain quality systems, perform analytical data review, support product and process assessments, and prepare for internal and external regulatory inspections.
• Participate in customer complaint investigations, stability and analytical data review, and disposition of API intermediates and raw materials.
• Contribute to quality system improvement and mentoring of QA Specialists.

Skills

Quality Assurance

GMP Compliance

Statistical Analysis

Deviation Management

Change Management

Inspection Readiness

Manufacturing Experience

Education

Bachelor's degree in Chemical Engineering / Biomedical Engineering / Pharmacology

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work- but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly and Company seeks a Representative - QA - IAPI (R2-R3) to provide quality support to Indianapolis API Operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance. Review and approve key GMP documentation, contribute to deviation investigations and change control proposals, and provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations. Maintain quality systems, perform analytical data review, support product and process assessments, and prepare for internal and external regulatory inspections. Participate in customer complaint investigations, stability and analytical data review, and the disposition of API intermediates and raw materials. Contribute to quality system improvement and provide mentoring to QA Specialists. #LI-DNI

Position requires a Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or a related scientific field and 2 years of academic or employment experience with cGMPs and quality systems. Academic or employment experience must include: 2 years of experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs; 1 year of experience with statistical tools and analysis; and experience in Deviation Management, Change Management, and Inspection Readiness. Must support 24 hour/day operations. Part-time telecommuting may be permitted. #LI-DNI

Job location: Indianapolis, IN.

Rate of Pay: $71,531.00 - $101,275.00 per year.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$71,531.00 - $101,275.00 per year

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

#WeAreLilly