QA Floor Technician

Medasource; Pleasant Prairie (WI); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Quality Assurance – Floor Support to oversee GMP operations and collaborate across departments in Pleasant Prairie, WI. The role requires parenteral experience, adherence to cGMP requirements, and effective communication to resolve issues within manufacturing processes. This position entails 12-hour shifts on a rotating schedule, with a primary focus on maintaining quality standards and compliance.

Benefits

Medical insurance

Vision insurance

Qualifications

• Must have parenteral experience.
• Solid understanding of cGMP requirements preferred.
• Prior experience working in GMP-regulated manufacturing environments preferred.

Responsibilities

• Promote and maintain a safe work environment.
• Ensure compliance with site procedures and good documentation practices.
• Review and approve GMP records.

Skills

Aseptic gowning process experience

Sampling

Troubleshooting and root cause analysis

Technical writing proficiency

Education

High school diploma or equivalent education

Tools

Master Control

LabVantage

Veeva

Job description

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Direct message the job poster from Medasource

Position: Quality Assurance – Floor Support

Location: Pleasant Prairie, WI

Type: 6 month CTH

Schedule: 12 hour shifts, days or nights, 2-2-3

The Quality Assurance – Floor Support position is responsible for overseeing GMP operations during the day or night shift (not both). This role requires close collaboration across different departments and organizational levels, assisting with issue resolution and ensuring timely escalation of manufacturing concerns to site-based process teams. Oversight will be focused on one of the following manufacturing areas:

• Formulation and Equipment Preparation
• Parenteral Filling (Pre-Filled Syringes)
• Visual Inspection

Key Responsibilities:

• Promote and maintain a safe work environment, actively supporting health, safety, and environmental initiatives in alignment with corporate and site goals.
• Provide regular floor support by maintaining a consistent presence in assigned production areas.
• Ensure compliance with site procedures and good documentation practices.
• Review and approve GMP records, including annotations to electronic batch records and logbook entries.
• Assist in developing Standard Operating Procedures (SOPs), related forms, tools, and training materials.
• Troubleshoot and support the resolution of equipment alarms and other system issues within quality platforms like Master Control or other Manufacturing Execution Systems.
• Maintain clear and open communication with cross-functional teams and area leadership.
• Assist in inspection readiness activities and contribute to site self-inspection efforts.
• Support site project initiatives as needed.
• Promptly communicate compliance concerns to Quality Management.
• Assess potential product quality impacts for GMP incidents and aid in investigations.

Must have Qualifications:

• High school diploma or equivalent education.
• Parenteral experience
• Aseptic gowning process experience
• Sampling, whether from EM or production

Preferred Skills and Experience:

• Solid understanding of cGMP requirements.
• Prior experience working in GMP-regulated manufacturing environments.
• Proficiency in systems such as Master Control, LabVantage, and Veeva.
• Strong verbal and written communication skills.
• Effective interpersonal skills and the ability to work collaboratively within a team.
• Strong troubleshooting and root cause analysis capabilities.
• High attention to detail with a focus on maintaining compliance within quality systems.
• Ability to independently and collaboratively solve problems.
• Technical writing proficiency.

Additional Information:

• Primary work location: Kenosha County, Wisconsin.
• This position requires 12-hour shifts on a rotating 2-2-3 (or similar) schedule during the day or night shift. Remote work is not available for this role.
• Overtime and support during off-shift hours may occasionally be needed.
• Responsiveness to urgent operational issues outside of normal business hours may be necessary.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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