Quality Assurance Batch Release Associate - Drug Product External Manufacturing

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, Central and South 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

Work 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.

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 to finished product)

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 CM

Complete other duties as assigned

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; parenteral 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, Regulus)

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

Technical understanding of cGMPs and the Global Quality Standards

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 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.

WeAreLilly