Overview
Quality Technician Jobs in Manitowoc, WI at WST FAB LLC
Position Summary:
The Quality Assurance Manager oversees, participates in, and manages all Quality Assurance (QA) activities. The roles works collaboratively across internal functions including Analytical/Process Development, Regulatory Affairs, and Supply Chain to ensure QA deliverables are met. It acts as a point of contact (POC) and QA matters, internally and externally.
Responsibilities: Responsibilities include but are not limited to:
Oversee and manage Quality Assurance practices in compliance with GMP, including reviewing and approving GMP documentation and preparing lot release documents.
Act as a first responder for on-floor quality issues, assist in documentation and corrective actions, and track and report lot disposition status.
Ensure compliance with cGMP requirements, stay updated on regulatory changes, and collaborate cross-functionally to resolve technical issues.
Conduct and manage internal and external audits, train employees on GMP compliance and quality standards, and analyze quality data to identify improvements.
Manage customer complaints, non-conforming product issues, and liaise with vendors for regulatory information and customer inquiries.
Manage, hire, terminate, and train Quality Assurance personnel, including performance reviews and scheduling activities.
Implement and monitor key performance indicator (KPIs) for the QA department, manage the Quality Assurance budget and optimize expenses.
Support the ongoing evolution of FDA requirements and perform other tasks as assigned by Management.
Preferred Qualifications:
Experience with FDA audits and regulatory inspections.
Certification in Quality Management (e.g., ASQ Certified Quality Manager).
Experience in a leadership role within a manufacturing environment.
Skills and Abilities:
Critical eye for detail and accuracy.
Resourceful, self-motivated, and works well in a fast-paced environment.
Proficient with Microsoft Office, including skills with Outlook, Word, Excel, and Adobe.
Excellent verbal and written communication skills in English.
Ability to work independently and in a team.
Salary:
$65,000.00 – $75,000.00
Benefits:
Paid Time Off
Sick Time
Paid Holidays
401(k)
Health Insurance
1-4 Company Events per calendar year
Hours:
Monday – Friday (40-hours per week)
Language:
English (Required)
Work Location:
Largo, FL (In-person)
Ability to commute and/or relocate prior to starting (Required).
Job Type: Full-time
Pay: $65,000.00 – $75,000.00 per year
Benefits:
401(k)
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Experience:
FDA regulations: 4 years (Preferred)
Ability to Commute:
Largo, FL 33773 (Preferred)
Ability to Relocate:
Largo, FL 33773: Relocate before starting work (Preferred)
Work Location: In person
Title: Quality Technician
Company: WST FAB LLC
Location: Manitowoc, WI
