QA Person in Plant - Drug Product External Manufacturing (Virginia)

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.

Responsibilities

The QA Person in Plant (PIP) is responsible for leading a cross-functional team comprised of Lilly representatives. Additional responsibilities include helping and guidance on issues such as deviation investigations, change control proposals, procedure/master formula revisions, and other daily duties.

The QA PIP may also be responsible for the final disposition of manufactured and/or packaged drug product batches. This role serves as Drug Product External Manufacturing (DPEM) QA for initial escalation and works with both Lilly employee and representatives from the Contract Manufacturer as part of the Joint Process Team (JPT) to ensure timely responses to requests for information. They ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes, and comply with cGMP and regulatory requirements.

Key Objectives/Deliverables

• QA Person in Plant should understand the process and equipment for their product scope, including:
• Understanding the science behind the process and equipment so that compliance-based decisions ensure ongoing effective and efficient processes.
• Knowing how upstream/ downstream processing is affected by their process steps.
• Knowing the Operational Control Strategy (OCS) and failure modes of the process.
• Knowing the historical deviations/gaps, trends, and audit history of the process.
  
  

• QA Person in Plant should provide support to daily operations by:
• Levelling, reviewing, and approving of event investigations and changes.
• Ensuring implementation and effectiveness of corrective and preventative actions.
• Reviewing that practice matches procedure.
• Ensuring quality systems are compliant with applicable GMPs, Lilly quality standards and any additional local market requirement.
• Contribute to Quality culture efforts at both DPEM and JPT.
• Spend time in all unit operations, including the lab.
• Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult)
• Support onsite resolution of product related issues.
• Ensure compliance to data integrity (i.e. perform audit trail reviews)
• Perform trouble shooting for in process issues and escalate as needed.
• Review and provide approval for JPT procedure changes.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Participate on Joint Process Teams (JPT)
• Review, enter, or SPV analytical data and escalate as needed.
• Ensure batches are identified and appropriately sampled for annual stability requirements.
• Provide on-site support for GQAAC audits and Regulatory inspections.
• Review and approve complaint investigations.
• Consult on Master batch record updates; provide input based on observations and interactions on the floor.
• Metrics tracking
• Assist in gathering data to complete Site Compliance Reports (SCR); provide review as needed.
• Perform internal notification of quality issues where needed.
• Ensuring that materials and products manufactured at JPTs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market.
• Participate in JPT performance reviews (Ex IOPs, supply management …etc.)
• Track and monitor quality metrics for trends.
  
  

• Support batch release activities by:
• Complete batch record and media fill reviews (parenteral), reporting any issues.
• Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
• Originate and investigate deviations associated with batch records.
• Work with Lilly support groups to resolve product related issues.
• Create Certificates of Analysis or other similar documentation for internal and external customers as needed.
• Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product).
• Provide support for Notification to Management data gathering.
• Provide input for metrics reports to management.
• Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers.
  

Relationships

• Develop and maintain strong working relationships with JPT primary DPEM contacts, QA/QC personnel and shop floor personnel.
• Ensure JPTs are following Quality Agreement and appropriate quality systems as part of routine operations.
• Assist QA Primary loop role with providing potential topics for GQAAC audit of the JPT.
• Assist JPTs on the preparation of any audit from Lilly (GQAAC) or any external agency inspection that impact Lilly products.
• Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the JPTs is taking appropriate actions in the due time.
  
  
  

Continuous Improvement

• Support continuous improvement initiatives with JPT (i.e. identify vulnerabilities and inefficiencies of the process and promote improvement projects.
• Ensure quality improvements are managed through the GMP plan process. Ensure evidence of completion and completes in a timely manner.
  
  
  

Basic Qualifications

• Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science or equivalent experience.
• Minimum 3-5 years of experience supporting quality functions, preferably within a parenteral manufacturing site.
  
  
  

Skills

• Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence JPTs.
• Demonstrated ability to work independently.
• A thorough understanding of cGMPs and Global Quality Standards.
• Strong written and communication skills, especially attention to detail in written procedures and protocol development.
• High learning agility.
• Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
• Ability to organize, prioritize, multi-task and influence others.
• Strong decision making and problem-solving skills.
• Willingness to learn new technologies.
• Capability to work in a virtual and complex environment.
• Willingness to travel.
• Appreciation for cultural diversity.
  
  
  

Additional Skills/ Preferences

• Regulatory related experience.
• Established technical, quality, and internal networks.
• Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
• Previous experience supporting batch release for parenteral and/or packaging products may be preferred.
  
  
  

Additional Information

Shift is days, but schedule flexibility and off hours may be necessary to support operations.

Some travel (<10%) is required primarily to Indianapolis, Indiana.

This role requires on-site presence a minimum of 3 days per week. In order to fulfill this on-site commitment, employees are expected to travel (by car) 3 times/week to the site. Relocation is available.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$63,000 - $162,800

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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