Medasource
Apply Now
Position: Quality Assurance – Floor Support (Day or Night Shift)
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.
LKC QA Floor Technician Pleasant Prairie, WI
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
JO-2504-167698