Lead Quality Control Analyst

The health and safety of our employees and candidates is very important to us.

Due to the current situation related to the Coronavirus (COVID-19), we’re leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda.

As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey.

If so, one of our colleagues will explain how these tools will be used during the recruitment process.

Thank you.

*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers.

See below or here for more info.

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare.

They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients.

Life-changing for you.

Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation.

As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Success

What makes a successful member of our team?

Check out the traits we’re looking for and see if you have the right mix.

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 with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Summary:

To support laboratory projects activities, conduct biological, chemical and physical analyses by using sophisticated laboratory instrumentation and computer systems to collect and record data.

To be familiar with analytical, biological, chemical and Lean principles, GDP, cGMP, SOPs, FDA, and QSR regulations.

Contribute to a team setting within the laboratory and or other departmental personnel to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

Essential Duties and Responsibilities:
Support laboratory projects activities: conduct biological, chemical and physical analyses on test samples following procedures; help prepare and complete technical documentation.

Work under minimal Supervision.

Use sophisticated laboratory instrumentation and computer systems to collect and record data.

Perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles.

Perform review and evaluation of test data with application of GDP.

Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Supervisor.

Prepare lab protocol studies/validations with some supervision.

Familiarity with code of federal regulations, and compendia requirements.

Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations Use Global LIMS or other computerized systems for entering and approving test results as applicable Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

Ensure area is maintained in a GMP state at all times while following all EHS and 5S guidelines.  Prepare and update SOPs as required under supervision.

Perform equipment maintenance and calibrations as required Apply Lean principles such as 5S throughout daily work activities Ensure personal training requirements are met and that training records are current.

Train staff per project needs.

Perform Disposal of Hazardous Waste (as applicable)
Qualifications:
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.

Effective organizational skills and ability to plan and suggest resolutions to technical or resource problems.

Proficient in advanced wet and instrumental methods of analyses.

Demonstrated technical knowledge and experience in assays/equipment in functional area.

Proficient with lab application software and able to learn new computer systems and programs in a timely manner.

Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).  Must be detail oriented, conscientious and have a high reading comprehension skill.

Proficient understanding of laboratory instrumentation and chemical handling Effective interpersonal communication and influencing skills.

Must have effective verbal and written communication skills.

Effective presentation skills a plus.

Must be able to understand and apply cGMP/DPD, follow CTP/SOPs, and meet EHS requirements.

Education and/or experience:
Typically requires bachelor’s degree in chemistry, biological science, or other related technical field.

2+ years of related experience 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.

Must be able to work overtime as required (APPLICABLE TO SNE only).

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

Check out where you could be
working if you apply.

Job Seekers: Protect yourself against identity theft

Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information.

They visit job-related websites and invite candidates to online chats.

During the chat, they press job seekers to provide bank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited.

All rights reserved.

Related Post