Quality Specialist - Aseptic
About The Position
The Quality Specialist supports food safety, quality assurance, and regulatory compliance programs within an aseptic food manufacturing facility. The role helps ensure products are manufactured in accordance with FDA regulations, HACCP requirements, Preventive Controls, customer specifications, and company quality standards. The specialist works with Production, Maintenance, Sanitation, and Supply Chain to maintain aseptic process integrity, investigate quality issues, and drive continuous improvement. The position is responsible for reviewing and reconciling batch records and associated documentation, maintaining release records, retrieving and filing sterility-cycle data, coordinating secondary reviews, and escalating deviations or out-of-specification results. It also coordinates laboratory testing and release timelines for products requiring expedited release, assists with material extensions and investigations, supports secure storage of older batch records, and establishes and monitors batch-release performance indicators. The role is on-site at the manufacturing plant in Indianapolis, Indiana.
Requirements
- Bachelor’s degree in science.
- 1–2 years of experience in a food manufacturing environment.
- Strong expertise in Quality Assurance and Good Documentation requirements.
- Strong organizational and leadership skills.
- Demonstrated ability to work with cross-functional departments.
- Strong verbal and written communication skills.
- Excellent analytical, problem-solving, and corrective-action/resolution skills.
- Strong computer skills, including experience with Word, Excel, and PowerPoint.
- Understanding of regulatory requirements for food safety.
- Ability to perform some release activities during off hours.
Nice To Haves
- Better Process Control School.
- Low Acid Canned Food experience.
Responsibilities
- Ensure batch records comply with requirements for final release decisions.
- Maintain the release spreadsheet documenting review and release for the Aseptic Department.
- Reconcile batch records and ensure all documents pertaining to each batch are filed.
- Retrieve data and print sterility-cycle graphs and logs for filing with batch records.
- Review documentation, identify necessary corrections, and return documents to Production.
- Submit processing documentation and graphs/logs to the QA Supervisor and/or Heartland Process Authority for secondary review.
- Escalate deviations and out-of-specification results to the QA Supervisor.
- Coordinate expedited product testing with Analytical and Microbiological Laboratories.
- Coordinate urgent product-release timelines with Commercialization Managers or Warehouse Supervisors.
- Assist the QA Supervisor with material extensions, CAPA investigations, deviations, and derogations.
- Coordinate secure storage of older batch records with the Warehouse.
- Develop and sustain relationships with Quality Assurance, Operations, and Planning.
- Establish, implement, and monitor key performance indicators for batch release.
- Perform other duties as assigned.
Benefits
- Excellent compensation and benefits package.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
