QC Analyst I - United States
- Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.
- Conduct critical biological test methods including samples generated for in-process, drug substance and stability.
- Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS).
- Follow SOPs to perform methods requiring precise analytical skills and understanding of biology and chemistry principles.
- Demonstrate a functional understanding of a laboratory setting and Standard Operating Procedures (SOPs).
- Complete all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Exercise judgment within defined Quality Control procedures and practices to determine appropriate action.
- Initiate low severity level deviations, CAPAs and change controls within the electronic Quality Management System.
- Occasionally participate in functional efforts involving teams to solve problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
- Author minor revisions to existing SOPs.
- Receives general instructions on routine work and detailed instructions on new assignments.
- May be required to work overtime or be assigned to a different shift as needed.
- May perform equipment maintenance and calibrations as required.
Bachelor’s or Master’s Degree in any Life Sciences with relevant laboratory coursework and 0-3 years of relevant experience.
- Previous experience in a regulated environment desirable.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must have basic understanding of laboratory instrumentation.
- Must be able to communicate effectively with supervisors and peers.
- Must be able to read, write and converse in English.
- Must be computer literate. Able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
ANALYTICAL CHEMISTRY SKILLSET:
The familiarity or experience with the following assays:
- Protein A HPLC
- Polysorbate 80
- Karl Fischer
- Appearance (Color, Clarity, Visible Particulates)
- Particulate matter
- In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 5% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.