IDAP Batch Disposition
About The Position
The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Quality Assurance Representative has oversight for the final disposition of semi-finished and/or finished drug combination products and packaging products including vials and dry. As the authorized quality representative, serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there is adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.
Requirements
- Bachelor's Degree (Science or Engineering related degree preferred)
- At least 5 years working in the pharmaceutical or medical device industry in QA roles.
- Previous batch disposition experience supporting device, parenteral or drug substance products/materials.
- 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.
Nice To Haves
- Proficiency with applicable computer systems.
- Demonstrated strong oral and written communication skills.
- Demonstrated interpersonal skills and the ability to work as a team.
- Root cause analysis / troubleshooting skills.
- Demonstrated attention to detail and ability to maintain quality systems.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Proven ability to work independently or as part of a team to resolve an issue.
- Previous experience with Lilly Event and Change Management process.
- Proficiency with SAP, MES (PMX, Pharma Suite), and Darwin.
- Previous experience in GMP QA is desirable.
- Technical Writing and Communication Skills.
Responsibilities
- Performs batch disposition of incoming materials, semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
- Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Batch / Batch Disposition.
- Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
- Participate in self-led inspections and/or provide support during internal / external regulatory inspections.
- Effectively review / approve GMP documents to ensure quality attributes are met (i.e. Non-conformances, procedures, protocols, specifications, and change controls).
- Participates in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
