Job Description

About the Role:

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)

How You Will Contribute:

• 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.

What You Bring to Takeda:

• 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 implementation required.
• Strong verbal and written communication skills, including the ability to read and follow detailed written and electronic instructions and communicate technical or operational information effectively required.
• Strong interpersonal and relationship-building skills with the ability to work effectively with team members, supervisors, managers, senior leadership, and cross-functional partners required.
• Ability to effectively manage competing priorities, work independently, and make sound decisions while maintaining quality and compliance required.
• Proficiency with Microsoft Office applications, including Excel, PowerPoint, Word, and Teams required.
• Demonstrated professional maturity, empathy, accountability, and ability to provide constructive feedback while fostering a collaborative and productive team environment preferred.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing and laboratory environments to ensure we protect the quality of our products. In this role, you may:

• Facilitate or deliver training during off-shift hours as needed.
• Work multiple shifts, including weekends and off-shift hours, and work supplemental hours as necessary to support business needs.
• Lift, push, pull, and carry up to 50 lbs.
• Work in controlled environments requiring special gowning and follow gowning requirements, including wearing protective clothing over the head, face, hands, feet, and body as required.
• Wear personal protective equipment (PPE) and cleanroom garments, which may include safety shoes, safety glasses, aprons, face shields, lab coats, full-body gowns, hair nets, gloves, and hearing protection.
• Remove makeup, jewelry, contact lenses, nail polish, and/or artificial fingernails while working in manufacturing environments.
• Work in cold and wet environments.
• Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
• Speak, read, write, and follow detailed written and oral instructions in English.

For Location:
USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range:
$71,800.00 - $112,860.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

Locations
USA - GA - Social Circle - Hwy 278

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes