Quality Assurance On-the-Floor Specialist (Aseptic Manufacturing)

FUSTIS LLC; Indianapolis (IN); On-site; USD 55,104 - 68,880; Full time

Job summary

A pharmaceutical contractor in Indianapolis is seeking a QA contractor for onsite support in aseptic drug product manufacturing. The role involves daily quality oversight, ensuring GMP compliance, reviewing batch records, and supporting investigations. Candidates must have a Bachelor’s degree in a scientific field, 5-7+ years of experience in cGMP pharmaceutical manufacturing, and strong communication and organizational skills. This position offers an hourly pay rate of $40/hr. (W2) or $50/hr. (1099).

Qualifications

• 5-7+ years of cGMP pharmaceutical manufacturing experience, preferably in Quality Assurance.
• Strong knowledge of manufacturing processes and quality systems.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Maintain strong presence on the manufacturing floor and participate in QA walkthroughs.
• Review batch records, assess deviations, and support investigations.
• Escalate critical issues and act as quality liaison across teams.
• Coach operational teams to maintain GMP compliance.

Skills

Excellent communication

Problem-solving

Organizational skills

Knowledge of GMP documentation

Proficiency in Microsoft Office

Proficiency in QMS systems (e.g., Veeva Vault)

Education

Bachelor’s degree in a scientific field

Job description

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