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Sr Quality Technician
This position reports to Night (3) shift. This shift schedule is Monday-Friday from 10 PM to 6 AM. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Successfully perform all primary activities for Pharma and Fractionation/Teardown Quality Assurance which include providing daily quality assurance to operations, review and release of batch records and associated documents within the manufacturing facility. Provide Quality Assurance support to Site Critical Systems, Facilities and Engineering processes as necessary. Individual is expected to contain situation, gather information and escalate to the appropriate stakeholder as necessary. Assurance compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda Quality practices. Review and release batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc. Provide support on change control processes and participate and support internal and external audits. May be required to provide assessment to support day to day change control processes (insignificant changes and return to operations) in accordance with internal procedures and ensure compliance with the FDA and ISO requirements. Good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements.
- Support and provide on shift guidance and support for site operations
- Partner with shift manufacturing to ensure sound quality decisions are made.
- Provide oversight to ensure a GMP area is maintained for the Building 5 and Building 8 area on shift.
- Obtain resolution on areas identified as non–conformance. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.
- Performs initial investigations and reviews Deviations, CAPAs, and User Interventions.
- Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.
- Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
- Assist in initial investigation and risk assessments
- Identify areas of improvement and drive for continuous improvement
- Work with change owners to ensure change packages are accurate and meet requirements set forth.
- Develop, lead and execute project(s) as assigned by management.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
- Assist in external and internal audits by collecting and reviewing documents as assigned by management.
- Provide guidance and training of employees within the department.
- Provide guidance to members of other departments with regards to critical step verification.
- Support activities for another section or department as assigned by management.
- Have strong interpersonal skills
- Have the ability to operate in a dynamic, cross-functional environment.
- Be able to be flexible.
- Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.
- Be able to have great attention to detail is necessary.
- Be able to handle multiple tasks and projects concurrently
- Have strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Have good critical thinking and problem solving skills (DMAIC, Six Sigma, and Lean).
- GEMBA - good investigational experience who goes to the floor see the actual process where event occurred and who also implement robust Corrective Actions for the correct Root Causes.
- Yellow Belt/Green Belt training/certification preferred.
- Have good verbal and written communication skills.
- Have general knowledge of biotech manufacturing theories and processes.
- Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).
- Be able to perform and analyze trending through the use of DeltaV system and/or EBM.
- Be able to generate spreadsheets and power point presentations on the computer.
- Be able to support departmental / plant goals.
- Be able to review and approve investigations
- Be able to work independently and with intermittent supervision.
Bachelor's degree in science, engineering or other related technical field strongly preferred. 2+ years of related experience.
- Must be able to lift, push, pull and carry up to 25 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to 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.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends, as assigned.
- Must be able to work overtime as required.
- May be required to work in a confined area.
- Some clean room and cool/hot storage conditions.
Location and Salary: Excludes Colorado