Quality Associate I - QA Ops (Second Shift)

Takeda Pharmaceutical Company - Round Lake, IL

Full-time - Entry Level

Round Lake, IL

Chemical Manufacturing

About the position

The Quality Associate I - QA Ops (Second Shift) role at Takeda involves overseeing quality assurance processes in a manufacturing environment. The position focuses on materials release, documentation approval, and quality oversight on the production floor. The associate will work second shift hours from 4:00 PM to Midnight, Monday through Friday, ensuring compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Responsibilities

• Responsible for raw material and bulk container receipts, release, and investigation of any issues found.
• Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
• Oversight of quality line operations concerning product quality and conformance to regulations and Takeda quality procedures.
• Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
• Identify and assess quality risk in production operations daily.
• TIQ/QOTSF review of checklists and trending of observations for monthly quality council.
• Develop training materials and procedures and participate on teams to implement process improvements.
• Complete interfacility impact assessments for product/process changes.
• Manage investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
• Participate in internal and external regulatory audits and present to auditor.

Requirements

• Bachelors' degree in science, engineering, or other related technical field.
• Some related experience in quality assurance or manufacturing.
• Knowledge of the local and international regulatory environment and regulations for the manufacture of biological products.
• Ability to walk 1-3 miles and lift 10 lbs.

Nice-to-haves

• Experience with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Familiarity with artwork management software.

Benefits

• Medical, dental, and vision insurance coverage.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Sick time and paid vacation accrual.