Quality Assurance Specialist

1 day ago

Round Lake, Illinois, United States Takeda Pharmaceutical Full time
About the Role:

The primary responsibility of this position is to ensure the quality and compliance of our manufacturing processes. As a Quality Assurance Specialist, you will be accountable for overseeing the release and approval of completed documentation for batch folders, following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines. You will also be responsible for trending of observations from the floor to improve them and for manufacturing support activities, including revising Standard Operating Procedures (SOPs) and forms, and developing training materials.

Key Responsibilities:
  • Responsible for raw material and bulk container receipts, release, and investigation of any issues found, following up with appropriate Takeda facilities for documentation correction.
  • Manufacturing support activities, including batch record documentation, issuance of Batch records, 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, review of checklists and trending of observations for monthly quality council, and responsible for TIQ/QOTSF program management.
  • Develop training materials and procedures and participate on cross-functional teams to implement process improvements, be a Subject Matter Expert (SME) and provide training to employees needed on relevant areas.
  • Demonstrate effectiveness in task completion and empowerment of others, deviation/nonconformance management, training, and problem-solving.
  • Complete interfacility impact assessments for product/process changes.
  • Manage root cause 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 as a SME for Quality operations and present to auditor.
Requirements:
  • Typically requires a bachelor's degree in science, engineering, or other related technical field, with some related experience.
  • Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
  • Analytical and problem-solving skills.
  • Acts as a change agent to sufficiently motivate team members to achieve team goals.
  • You must not be allergic to Cephalosporin drugs.
  • Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.
  • Indoor working conditions.
Important Considerations:

At Takeda Pharmaceutical, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

  • May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets, and gloves and hearing protection.
  • Need to remove all make-up, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
  • Work in a cold, wet environment.
  • Work multiple shifts, including weekends, or be asked to work supplemental hours.
  • Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.

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