Principal/Sr. Associate-QA-API External Manufacturing

BioSpace; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Pension

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks an API EM Quality Assurance Consultant to oversee quality activities at Contract Manufacturing sites. You will ensure batches meet specifications, comply with cGMPs, and support regulatory commitments.

You will coordinate QA responsibilities for API shipments, participate in inspections, and work with Lilly QA management to drive quality improvements across manufacturing operations. A science degree and GMP experience are required.

Qualifications

• Bachelor's degree in a science-related field required.
• At least 2 years GMP manufacturing experience in API/pharma.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Serve as liaison between Contract Manufacturers (CMs) and Lilly for quality issues.
• Provide quality oversight of CMs and be the initial point of contact for QA matters.
• Escalate quality issues to Lilly QA management and ensure corrective actions.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs and review documentation prior to batch release.
• Participate in regulatory inspections and provide on-site support during inspections.
• Review and approve documents including procedures, MBRs, deviations, and change controls.
• Participate in productivity and process improvement initiatives.

Skills

Quality assurance

Regulatory knowledge

Quality systems

Communication

Education

Bachelor's degree in science

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.

The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’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

• Serve as a liaison between CMs and Lilly.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/APIEM Quality Plans
• Coordinate and perform QA responsibilities of API shipments from suppliers and CMs.
• Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
• Participate on the Technical Review Board
• Evaluate and disposition API batches, if required.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
• Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Basic Requirements

• Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• At least 2 years previous GMP manufacturing experience in API or Pharma experience in finished product manufacturing, QC, QA or Engineering.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Experience in quality support for Quality Control activities
• Thorough technical understanding of quality systems and regulatory requirements.
• Knowledge of pharmaceutical manufacturing operations.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.

Other Information

• Must complete required training for API EM Quality Assurance.
• No certifications required.
• Must be able to support 24-hour/day operations.
• Continental and Intercontinental travel may occur (20%)

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
$65,250 - $169,400

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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