Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Control Analyst II in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a QC Analyst II working on the Quality team, you will be empowered to conduct critical biological test methods and maintain compliance with cGMP regulations, and a typical day will include:
- This position will 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 routine and non-routine methods requiring precise analytical skills and understanding of biology and chemistry principles.
- Demonstrate a functional and basic theoretical understanding of laboratory operations 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 generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
- Decisions have moderate impact on future Quality Control processes and procedures.
- Initiate and own deviations, CAPAs and change controls within the electronic Quality Management System.
- Occasionally participate in cross-functional efforts involving teams.
- Drafts studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors.
- Authors new SOPs and initiates changes to existing procedures.
- Receives general instructions on new assignments and limited instruction on routine work.
- May assist in training new QC Analysts on routine procedures and practices.
- May be required to work overtime or be assigned to a different shift as needed.
- May perform equipment maintenance and calibrations as required.
- May perform other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor s or Master s Degree in any Life Sciences with relevant laboratory coursework and 3-6 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.
BIO-ANALYTICAL CHEMISTRY SKILLSET
The familiarity or experience with the following assays:
- Protein A ELISA
- HCP ELISA
- Cell Adhesion Potency
- Binding Potency
- Binding ELISA
- Host Cell DNA
- 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
Learn more at takedajobs.com.
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
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