Title: Process Expert Deviation Investigator
Location: Indianapolis, IN – 46268
Duration: 6 Months
Shift: (Mon-Fri 8am - 5pm)
Onsite role Indianapolis
Description:
As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.
Key Responsibilities:
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols,and other documentation as needed.
• Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
• Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
• Ensure processes are always inspection ready.
• Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
• Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.
Role Requirements
• Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
• 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Strong awareness of quality issues. Compliance investigations experience required.
• Excellent technical writing skills
Desirable Requirements:
• Previous Radio pharma experience a plus
• Prior leadership and/or high cross-functional experience preferred.
...About Us We are a busy, established, and team-oriented salon looking for a motivated leader to help us provide a... ...staff and clients. While you wont be required to cut hair, youll play an essential role in managing daily operations, supporting our stylists, and...
...Job Description Marine Structural Welder Aluminum Core Welding Skills both GMAW & GTAW GMAW (Pulse / Spray) All Positions Must be able to perform argon-purged open root GMAW welds. Capable of producing X-Ray (RT) quality welds in all positions....
Job Opportunity At SynergisticIT SynergisticIT wants every candidate to know that the job market is challenging and that to stand out, you need to have exceptional skills and technologies. SynergisticIT understands the complex nature of the job market and how difficult...
...Job Description NNS- Lead Low Voltage Security Technician \n \n Compensation \n \n ~ Hourly paid weekly $26-$36 per hour... ...certifications called out below as well as 5 years commercial construction installation experience specifically related to physical Security...
...special place Sunrise is to be a part of. COMMUNITY NAME The Fairfax Job ID 2025-231930 JOB OVERVIEW The Dietary Aide is responsible for providing dining room services and/or tray delivery dining services to guests/residents in the community's...