QC Specialist I

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Job Description
About the role:
To lead and implement key laboratory workflow, projects, and operations activities. As required, conduct biological, chemical and physical analyses by using sophisticated laboratory instrumentation and computer systems to collect and record data. Knowledge of analytical, biological, chemical and lean principles, GDP, cGMP, SOPs, FDA, and QSR regulations. Lead and participate in a team setting as lab representative for operational, project or investigational activities, to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
How you will contribute:

• To lead and implement key laboratory workflow, projects, and operations activities. As required, conduct biological, chemical and physical analyses on test samples following procedures; prepare and complete technical and lab investigational documentation. Provide technical and general GMP guidance to other lab personnel. 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 as needed.
• Prepare lab protocol studies/validations as required.
• Knowledge of the 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
• Lead and participate in a team setting as lab representative for operational, project or investigational activities 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.
• 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).

What you bring to Takeda:
Typically requires bachelor's degree in science, engineering, or other related technical field. Bachelor's degree in chemistry or Biological Science is preferred.
Key skills, Abilities & Competencies

• Ability to handle multiple activities and projects concurrently and complete activities in a timely manner.
• Strong organizational skills and ability to plan and suggest resolutions to technical or resource problems.
• Expert and/or proficient in advanced wet and instrumental methods of analyses. Demonstrated strong 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.
• Apply 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.
• Expert understanding of laboratory instrumentation and chemical handling
• Strong interpersonal communication and influencing skills with other lab personnel as well as internal and external stakeholders. Effective verbal and written communication skills. Effective presentation skills a plus.
• Effective in providing technical, operational, and general GMP guidance to other lab personnel
• Understand and apply cGMP/DPD, follow CTP/SOPs, and meet EHS requirements

Physical Demands

• Must be able to lift, push, pull and carry up to 25 lbs.
• 20/20 near vision required (corrected as acceptable)
• Must be able to recognize and distinguish among the colors red, yellow, and blue.
• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

Base Salary Range: $54,600-$78,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience.
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• Inside working conditions.
• 5% travel as applicable.

More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1
EEO Statement
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.
Locations
USA - CA - Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time