Operations Associate - NW Indy
- Immediate Opportunities - Life Sciences
- Indianapolis, IN, USA
- Full Time
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking an Operations Associate.
The Operations Associate will provide liaison between Operations and Functional support. This position will provide support for relevant deviation management and change control, thereby providing a key role in backlog reduction. The Operations Associate will conduct root cause investigations and implement countermeasures; will help develop and monitor metrics; facilitate various Process Teams; support site safety goals; and provide back-up for Operations Managers.
• Serve as facilitator to the Bulk, Filling and Packaging Process Teams.
• Serve as the operational representative for new product / process introduction.
• Serve as liaison between Operations and the various functional departments to ensure smooth flow of communications.
• Serve as main investigator and lead for filling, packaging and bulk deviations.
• Ensure operational backlog is maintained at an acceptable level.
• Provide support for aseptic process improvement.
• Facilitate the compliance cGMPs and writing of SOPs. Provide support for all regulatory and client audits.
• Support investigation of all safety and environmental issues. Support improvement of safety processes in the operational areas.
• Audit the cleaning and maintenance of operational areas.
• Serve as a temporary supervisor in operational areas as needed.
• Work on special projects to improve yields, reduce waste and improve profitability and quality.
• Provide feedback to employees to improve performance.
• Train employees on new processes and tools.
• Bachelors or equivalent experience; Technical Degree preferred.
• 5+ years' experience in Parenteral Operations.
• Aseptic/Sterile processing or filling experience preferred.
• Profit center and/or cost center experience preferred.
• Excellent organizational and leadership skills. Ability to effectively manage change and promote continuous improvement.
• Ability to communicate and motivate a diverse workforce and work effectively at all levels in the organization. Ability to effectively interact with business partners and outside vendors.
• Skilled in problem solving techniques including the ability to work closely with peers and other departments to identify and solve complex technical, product, and production related issues.
• Ability to use personal computers and modern software programs found in a professional business setting.
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