Quality Control Analyst II, Weekend Nights Shift

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.

As a Quality Control Lead Analyst
, you will play a key leadership role in ensuring products meet the highest standards of quality, safety, consistency, and regulatory compliance throughout the production process. You will lead and support a team of QC professionals while overseeing day-to-day laboratory activities, testing, sampling, and data release to ensure departmental goals and production timelines are met.

In this role, you'll serve as a coach and technical leader, partnering with cross-functional teams to resolve quality issues, support investigations, identify opportunities for improvement, and drive initiatives that strengthen laboratory performance and operational excellence. You'll also help foster a strong culture of safety, compliance, employee development, and continuous improvement aligned with Takeda's site objectives.

Shift Requirements:
Thursday – Sunday (1:30 PM – 12:00 AM)

• Lead and support day-to-day QC laboratory operations by assigning work, monitoring performance, providing guidance and training, and ensuring sampling, testing, and data release activities are completed accurately and within required timelines.

• Promote a strong culture of safety, quality, and compliance by reinforcing safety protocols, conducting routine Gemba walks, ensuring adherence to cGMP and standard work requirements, and proactively escalating issues that could impact operations.

• Coach and mentor QC professionals, facilitate team meetings, provide constructive feedback, support employee development, and foster open communication and collaboration across the team.

• Perform and oversee routine and non-routine testing, maintain testing qualifications, and ensure laboratory activities are performed in accordance with established standards, SOPs, and applicable requirements.

• Support the development, review, and maintenance of SOPs, job aids, and related laboratory documentation, including redlining documents when updates are required.

• Prepare and communicate management updates, metrics, laboratory performance information, and operational issues in a timely manner; participate in daily tier meetings and other departmental forums as needed.

• Support internal and external audits and audit preparation, lead laboratory tours for visitors, and participate in Quality forums and investigational teams.

• Lead or support root cause analysis, investigations, CAPAs, and Change Controls, helping identify sustainable solutions and ensuring activities are completed within required timelines.

• Identify, prioritize, and drive remediation, continuous improvement, and cross-functional initiatives that improve safety, quality, customer satisfaction, employee development, laboratory efficiency, and overall performance.

• Own and manage special projects as assigned by the Quality Control Leadership Team (QCLT) and provide leadership support to the department as needed.

• Bachelor's degree in Science, Engineering, or another related technical field and 2+ years of related experience in a pharmaceutical or similarly regulated industry required.

• Experience working in a Quality Control, laboratory, manufacturing, or other regulated environment required.

• Demonstrated ability to lead, coach, mentor, and influence team members while supporting effective scheduling and execution of departmental activities required.

• Strong knowledge of cGMP requirements, laboratory practices, SOPs, and quality standards with the ability to reinforce compliance across the team required.

• Strong troubleshooting, problem-solving, and root cause analysis skills with the ability to identify sustainable solutions required.

• Demonstrated ability to identify improvement opportunities, collaborate with cross-functional teams, and drive initiatives through…