Hybrid Quality Assurance Batch Release Associate - Drug Product External Manufacturing presso Lilly

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.

Organization Overview:
Drug Product External Manufacturing – US (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

Responsibilities:
The QA Associate for Batch Release is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

• Complete batch record and media fill reviews, 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/release processes

• Work cross-functionally with Lilly support groups to resolve product-related issues

• Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders

• Create Certificates of Analysis or other similar documentation for internal and external customers

• Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.

• Assist in the establishment and revisions of Quality Agreements with affiliates and customers as needed.

• Provide support to ensure on time completion of Annual Product Reviews

• Provide support to launch new products/ packages/ contract manufacturers (CMs)

• Participate on Joint Process Teams

• Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions as required)

• Provide support for Notification to Management data gathering

• Provide input for metrics reports to management

• Complete process/productivity improvements and compliance projects as assigned

• Oversee the batch release qualification process, benchmark with internal organizations, and implement improvements

• Contribute to Quality culture efforts at both DPEM and CMs

• Complete other duties as assigned

• Recommend, support and drive cross-functional and interdepartmental continuous improvement efforts

Basic Requirements:

• Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience

• Minimum 3 years of experience in regulated manufacturing industry and/or quality experience; direct parenteral, device assembly, or final packaging experience preferred

Additional Skills/Preferences:

• Proven ability to work independently or as part of a team to problem solve

• Experience with Pharma industry electronic systems (SAP, Trackwise, QualityDocs (Veeva))

• Previous experience with batch disposition for drug product manufacturing and packaging processes

• Technical understanding of cGMPs and Global Quality Standards/Quality Systems

• Knowledge of Pharmaceutical Manufacturing Operations

• Strong written and verbal communication skills

• Teamwork and interpersonal skills exhibited across functional areas

• Ability to organize, prioritize, multi-task, and influence diverse groups

• Strong decision making and problem-solving skills

Additional Information:

• Shift is days, but off-hours may be necessary to support operations

• Travel is possible, up to 10%

• This position is an onsite position that requires you to be onsite the majority of the time. This is not a remote position. Position is based out of Indianapolis, IN at Lilly Corporate Center.

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

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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