Quality Assurance Specialist II
Company: Takeda Pharmaceutical Company Ltd
Location: Los Angeles
Posted on: June 12, 2021
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.
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
- 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
- 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
- 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
- Strong organizational skills and ability to plan and suggest
resolutions to technical problems.
- Strong understanding of critical laboratory, manufacturing and
- Understand scientific strategies and be able to recommend
different technical strategies and analyses during
- 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
- Strong interpersonal communication and influencing/negotiation
skills. Must have strong verbal and written communication
- 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
- 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
- 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
- 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
USA - CA - Los Angeles
Keywords: Takeda Pharmaceutical Company Ltd, Los Angeles , Quality Assurance Specialist II, Other , Los Angeles, California
Didn't find what you're looking for? Search again!