Quality Assurance On-the-Floor Specialist (Aseptic Manufacturing)
FUSTIS LLC, Indianapolis, IN, United States
Overview
Location: Indianapolis, IN – 100% Onsite
Pay Rate: $40/hr. on W2 or $50/hr. on 1099
Role: Our client is seeking a QA on the floor contractor to provide daily quality oversight of aseptic drug product manufacturing operations. This role supports GMP compliance across manufacturing activities by partnering with operations to resolve quality issues, review documentation, and ensure inspection readiness within a parenteral manufacturing environment.
This contractor will maintain a strong presence on the manufacturing floor, participating in QA on the Floor walkthroughs, reviewing batch records and associated data, assessing deviations, and supporting investigations, change controls, CAPAs, validations, and process improvements. This role serves as a key quality liaison, coaching operational teams, escalating critical issues, and collaborating cross-functionally to support safe, compliant, and efficient manufacturing.
Responsibilities
Maintain a strong presence on the manufacturing floor and participate in QA on the Floor walkthroughs.
Review batch records and associated data, assess deviations, and support investigations, change controls, CAPAs, validations, and process improvements.
Escalate critical issues and act as a quality liaison across cross-functional teams to support safe, compliant, and efficient manufacturing.
Coach operational teams to maintain GMP compliance and inspection readiness.
Qualifications
Bachelor’s degree in a scientific field
5-7+ years of cGMP pharmaceutical manufacturing experience, preferably in Quality Assurance and parenteral products
Strong knowledge of manufacturing processes, quality systems, and GMP documentation
Excellent communication, problem-solving, and organizational skills
Ability to work independently in a fast-paced, onsite manufacturing environment
Proficiency in Microsoft Office and QMS systems (e.g., Veeva Vault)
Requires use of PPE and access to controlled manufacturing areas
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Location: Indianapolis, IN – 100% Onsite
Pay Rate: $40/hr. on W2 or $50/hr. on 1099
Role: Our client is seeking a QA on the floor contractor to provide daily quality oversight of aseptic drug product manufacturing operations. This role supports GMP compliance across manufacturing activities by partnering with operations to resolve quality issues, review documentation, and ensure inspection readiness within a parenteral manufacturing environment.
This contractor will maintain a strong presence on the manufacturing floor, participating in QA on the Floor walkthroughs, reviewing batch records and associated data, assessing deviations, and supporting investigations, change controls, CAPAs, validations, and process improvements. This role serves as a key quality liaison, coaching operational teams, escalating critical issues, and collaborating cross-functionally to support safe, compliant, and efficient manufacturing.
Responsibilities
Maintain a strong presence on the manufacturing floor and participate in QA on the Floor walkthroughs.
Review batch records and associated data, assess deviations, and support investigations, change controls, CAPAs, validations, and process improvements.
Escalate critical issues and act as a quality liaison across cross-functional teams to support safe, compliant, and efficient manufacturing.
Coach operational teams to maintain GMP compliance and inspection readiness.
Qualifications
Bachelor’s degree in a scientific field
5-7+ years of cGMP pharmaceutical manufacturing experience, preferably in Quality Assurance and parenteral products
Strong knowledge of manufacturing processes, quality systems, and GMP documentation
Excellent communication, problem-solving, and organizational skills
Ability to work independently in a fast-paced, onsite manufacturing environment
Proficiency in Microsoft Office and QMS systems (e.g., Veeva Vault)
Requires use of PPE and access to controlled manufacturing areas
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