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Lead QA Technician
Successfully perform all primary Quality Assurance activities for Teardown/ Fractionation (B5) or Purification (B8), which include providing daily Quality on the Shop Floor oversight: manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and timely resolution of issues, participating in trouble shooting and problem solving of manufacturing issues as well as supporting day to day change control processes (insignificant changes and return to operations) in accordance with FDA and Regulatory standards, ISO requirements and internal standard operating procedures.
Assure compliance with cGMP, GDDP and company procedures and support internal and external audits. Identify potential Quality and compliance risks in activities and processes according to procedural requirements, Takeda Quality Standards and practices. Provide assessments to support current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements. Uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.
Essential Duties and Responsibilities:
- Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
- Review and release batch records and associated documents against Standard Operating procedures and internal guidelines as assigned.
- Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities and supporting areas for verification of acceptable cGMP Facility and equipment conditions and resolution of actions.
- Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements.Obtain resolution on issues identified as non–conformance.Provide guidance on documentation of issues with immediate corrections and corrective actions.
- Work closely with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, generate cost savings, and provide new product support.
- Perform initial investigations and reviews Deviations, CAPAs, and User Interventions, etc.
- 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.
- 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, prepare and issue reports as defined by the area.
- Assist in internal self-inspections and external audits by collecting and reviewing documents as assigned by management.
- Provide guidance and training of employees within the department as assigned by management.
- Provide guidance to members of other departments with regards to critical step verification.
- Support activities for other departments as assigned by management.
- Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
- General knowledge of biopharmaceutical/ biotech manufacturing theories and processes.
- Good investigational experience.Ability to see the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections and robust corrective actions for determined root cause.
- Good verbal and written communication skills.
- Strong interpersonal and partnering skills.
- Ability to operate in a dynamic, cross-functional, fast paced environment.
- Be able to be flexible and accept new assignments.
- Result driven with ideas to drive continuous improvement and process simplification with breakthrough solutions.
- Have great attention to detail.
- 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 and Lean).
- Be able to perform and analyze trending using DeltaV system and/or EBM.
- Be able to generate spreadsheets and prepare reports and Power Point presentations on the computer.
- Be able to support departmental / plant goals.
- Be able to review and approve investigations as assigned
- Be able to work independently and with intermittent supervision.
- Yellow Belt/ Green Belt training/certification preferred.
Education and/or experience:
- Typically requires a 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 cGMP 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 Information: This post excludes CO applicants
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.