Quality Associate II

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Job Description

The Round Lake, IL Takeda manufacturing facility is expanding! Come join our Quality Team!

This position will facilitate and manage the closure of CAPA investigations, issues, customer complaint investigations, projects, and general requests for data, information, and reports related to the Takeda Round Lake plant.

Duties:

• Process complaints which may include:
  • Determine reportability of a complaint and submit associated regulatory reports within regulatory requirements
  • Work with Product Surveillance to evaluate complaint for need to investigate and coordinate sample retrieval
  • Document investigation, batch review and sample evaluation results
  • Coordinate timely closure of complaints, as per procedure
• Supports day to day management of the deviation and CAPA quality systems.  
• Ensure compliance to defined procedures and work with the facility to assess gaps and drive closure of implementation action plans.
• Prepare monthly, quarterly and annual complaint metrics/ trending for quality reviews.
• Maintain communication with Takeda facilities for batch release, document and data requests, coordination of inter-plant investigations, etc.
• Coordinates product holds, FCAs, and BPDNs/BPDRs as needed
• Supports annual product quality reviews, quarterly FDA reports.
• Assists the facility in preparation for quality audits and participate in corporate audits and external inspections.
• Works closely with manufacturing and product development teams and participate in proactive projects and teams that impact production, solve problems, improve quality, and provide support during investigations. 
• Other duties, tasks or projects as assigned.

• Excellent interpersonal and communications skills; exceptional attention to detail
• Ability to work well in a highly matrixed environment
• Demonstrated experience in managing complex projects
• Demonstrated knowledge of CAPA systems in cGMP environments
• Strong knowledge of cGMP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
• Training/experience in statistical tools, including lean and six sigma concepts 
• Excellent oral, written, presentation, and organizational skills, with the ability to handle a wide variety of tasks simultaneously with limited guidance
• Proficiency in Trackwise, and MS Word, Excel and PowerPoint
• Must not be allergic to Cephalosporins.

Education and Experience:

• Minimum Bachelor's degree in the sciences or engineering
• Minimum of 2 to 3 years of related work experience in a pharmaceutical or biotechnology organization in Quality, Regulatory, Product Development, or Manufacturing.

• Mostly sedentary work, sitting at a desk and working on a computer
• Walking through the manufacturing facility

• 90% working in an office environment / 10% working in manufacturing areas for investigations
• Occasionally work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment
• May work in a cold, wet environment
• May be required to work in a confined area
• May be exposed to some Clean Room and cool/hot storage conditions

Location and Salary Information: This job posting excludes CO applicants.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time