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Quality Assurance Specialist II
Plan, Develop, and Lead improvement and compliance projects relating to the QC Microbiology department. Responsible for basic project management and documentation authoring (e.g. change controls, protocols, reports, regulatory submissions, etc). Provide technical knowledge and/or support investigation teams for QC Microbiology related systems, processes, procedures, and test methods. Self-led individual that works under only very general supervision to meet deadlines/goals.
Essential Duties and Responsibilities:
- Lead projects across all shifts for the QC Microbiology department including indirect supervision of assigned personnel when supporting these activities.
- Interface with other functional areas and influence decision making on behalf of the QC Microbiology department to support departmental priorities and projects.
- Develop Project plans, change controls, generate protocols and final reports, revise local procedures, and manage other documentation to support the QC microbiology department.
- Support review of Global documents to ensure local compliance and evaluate gaps within the QC Microbiology department.
- Assist in the development, establishment and monitoring of systems that focus on key indicators within the QC Microbiology department.
- Be directly involved in and lead multiple process/product improvement projects. These projects may be executed through Deviations/CAPA, Belt Projects (Blue Belts / Green Belts), QWTs, Kaizens, or other focus groups.
- Provide subject matter expertise on the technical aspects of QC Microbiology.
- Assist in laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
- Lead in the development of customer awareness and support activities for QC Microbiology, and assist and drive such activities throughout the shifts.
- Operational liaison with various customers including Manufacturing, Quality Assurance and Process Development and Technical Services.
- Support Continuous Improvements in the QC Microbiology department; Support initiatives such as the site CI Master Plan, 5S, Visual Controls, VIPs, etc.
- Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.
- Strong organizational skills and ability to plan and suggest resolutions to technical problems.
- Strong understanding of critical laboratory, manufacturing and facility processes.
- Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.
- Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office). Capable of performing advanced data analysis through various applications software.
- Strong interpersonal communication and influencing/negotiation skills. Must have strong verbal and written communication skills.
- Represent the laboratory through technical presentations, management reviews, and other department presentations. Must be comfortable presenting effective presentations to stakeholders and to site management.
- Capable of applying decisions-making to problem-solve technical, compliance, or operational problems as assigned.
- Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
- Understanding of Data Integrity Principles is recommended.
- General knowledge of statistical techniques. Working knowledge of CFR, USP, and other compedial requirements that affect the QC Microbiology department.
- Proficient with wide variety lab application software.
Education and/or experience:
- Typically requires bachelor's degree in microbiology, chemistry, biological science, or other related technical field. 3+ 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, standing 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. This may include additional hearing protection for loud areas.
- 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.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- Will work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Must be able to work supplemental hours as necessary to complete work commitments.
- Inside working conditions.
- May infrequently need to travel to other local Takeda sites in Southern California, as assigned.
- 5% travel as applicable.
Location and Salary Information: This post excludes CO
EEO Verbiage for US Reqs
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.