Overview
Quality Engineer Jobs in Indianapolis, Indiana, USA at Synectics Inc.
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Description
We are looking for an experienced Quality Engineer with previous experience in a GMP pharmaceutical manufacturing environment to help us reach our ambitious goals.
As the Quality Engineer, you will be responsible for supporting the QA Operations organization in reviewing and approving technical records.
Your focus will be to support the design, construction, commissioning, qualification, and validation of the new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis, ensuring compliance with quality objectives and regulatory requirements.
Act as QA contact point and subject matter expert for activities related to manufacturing and QC areas during design, construction, commissioning, qualification, and validation.
Collaborate with the Site’s Manufacturing Science and Technology (MS&T) department to review and approve qualification and validation master plans for expansion projects.
Assist in creating and reviewing source documentation for regulatory submissions.
Support the preparation and execution of pre-approval inspections by FDA or other health authorities.
Under the guidance of the Quality Assurance Engineer Lead, perform triaging and initiation of events such as deviations, actions, CAPAs, etc.
Partner with cross-functional departments during triaging processes.
Support QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost efficiency, compliance, and data integrity.
Engage actively in process improvement and Right First-Time initiatives.
Ensure adherence to relevant regulations and quality standards.
Write and review Standard Operating Procedures (SOPs).
Requirements
Bachelor’s Degree, preferably in Life Sciences, Chemistry, or a related field.
Alternatively, 3-5 years of experience in a pharma industry role involving quality assurance.
At least 2 years of experience in GxP biopharmaceutical manufacturing operations.
Over 1 year of experience in a quality assurance role.
Open and clear collaboration and communication skills.
Experience with QA and QC in biotech pharmaceutical industry, especially environmental monitoring and cleanliness zones, is desirable.
Proven track record with cGMP requirements and practical experience.
Knowledge of FDA regulations and experience with US regulatory inspections.
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Title: Quality Engineer
Company: Synectics Inc.
Location: Indianapolis, Indiana, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
