TakedaPharmaceutical Nordics AB · 7 hours ago
Quality Control Technician II
Round Lake, IL
Full-time
Onsite
Entry Level
$18.85/hr - $29.62/hr
2+ years expTakeda Pharmaceutical Nordics AB is transforming patient care through the development of novel specialty pharmaceuticals. As a Quality Control Technician II, you will ensure compliance with procedures and regulatory requirements in the manufacturing facility, focusing on quality support and oversight of manufacturing operations.
Pharmaceuticals
Responsibilities
Performs Acceptable Quality Limit (AQL) sampling of finished product. Identifies and assess quality risk in production operations daily
Executes Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review of checklists. Programs are part of manufacturing support and compliance enforcement
Initiation of JDE (inventory management system and preventive maintenance system) work orders if required to address issues in timely manner
Performs sample management (Sterility, stability, etc.) to appropriate facilities and responsible for appropriate storage and disposal of retention samples. Samples Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories
Initiates investigations in the event of a failure pertaining to processes or Raw Material that is deemed to be out of specification
Performs triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate if needed
Facilitates kitting operations for packaging – issue and return of preprinted materials physically and electronically
Handles movement of materials/products physically and electronically for quarantine and reject areas
Review Lead Manufacturing support activities including batch record documentation review. Perform review and approval of batch documentation and consult with manufacturing to address any required corrections
Subject Matter Expert (SME) and provides training to other employees as required
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
Monitor product quality through the performance of required visual testing follow ups
Actively contribute to a team setting within quality operations and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support
Support regulatory audits as required
Qualification
Required
High School Diploma or GED with 2+ years of related work experience or Associates degree or higher and 1+ years related work experience
Solid interpersonal skills and great attention to detail
Team player with good problem solving, and good verbal and written communication skills
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Proficient in Microsoft Word, Excel, Outlook, and SharePoint
Able to work with JDE, EBM, TW workflows, Systech and other Learning Management and Document Management systems
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Accrue up to 120 hours of paid vacation
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase