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Job Description

Job Title: Quality Control Analyst II

Location: Social Circle, GA

About the role:

This position is responsible to ensure that products meet the highest standards of quality and consistency throughout the production process. Quality Control Lead is also responsible for leading a team of analysts, ensuring compliance with local, global, and regulatory standards are maintained. This position will support and drive improvements in safety, customer satisfaction, employee development, and continuous improvement, consistent with plant objectives. Additionally, the Lead Analyst is responsible for leading a team of QC professionals, conducting root cause analysis for defects, collaborating with cross-functional teams, and driving continuous improvement efforts to optimize quality and efficiency within the organization.

How you will contribute:

• Ensure the safety of all team members by promoting and enforcing safety protocols in the lab and work areas.

• Act as a coach and mentor, providing guidance and support for employee growth and development.

• Lead team meetings, fostering open communication and collaboration.

• Oversee and guide the team in day-to-day activities, ensuring smooth laboratory operations by assigning tasks, monitoring performance, and providing guidance and training to ensure high standards are maintained.

• Take ownership of area sampling, testing, and all laboratory processes.

• Ensure compliance with cGMP regulations by all team members, conducting routine Gemba walks to verify adherence.

• Manage departmental needs, ensuring that all testing and data are released within the required time frames (i.e. attend daily tier 1, tier 2, or other meetings)

• Perform routine, and non-routine testing as required

• Maintain testing qualification, and ensure adherence to standards

• Ensure the accuracy of operational SOPs; redline SOPs and related documents when updates are required.

• Prepare management updates, including metrics, in a timely manner.

• Actively participate in audits and audit preparation.

• Lead laboratory tours for internal and external visitors.

• Identify and drive the completion of remediation activities and continuous improvement initiatives. 

• Attend and participate in Quality forums and contribute to investigational teams as needed.

• Own and manage special projects as defined by the Quality Control Leadership Team (QCLT).

• Support owning, approving, and/or reviewing investigations, CAPAs, and/or Change Controls within the required time frames.

• Adhere to standard work requirements within the laboratory

• Author, review, and/or approve SOPs, job aids as needed

• Proactively escalate issues to the department manager/ supervisor as soon as they are identified, ensuring quick resolution and preventing delays in operations.

Complexity and Problem Solving

• Ability to support team through scheduling, coaching, and influential leadership

• Work with cross-functional team to identify improvement initiatives, and implement identified initiatives

• Troubleshooting, and/or problem solving and root cause analysis to ensure sustainable solutions.

Internal and External Contacts

• Supervisors, Managers, Associate Director, and other departmental leadership

• Compliance Team

What you bring to Takeda:

• Requires bachelor's degree in science, engineering or other related technical field. 2+ years of related experience in pharmaceutical or similar regulated industry.

Key Skills, Abilities, and Competencies

• Collaborative Teamwork & Interpersonal Relationship Building: Exhibits professional maturity and empathy, establishing & nurturing relationships within and outside the team.

• Effective Communication: Proficient in reading and following detailed written & electronic instructions, while demonstrating strong verbal and written communication skills.

• Cross-Functional Collaboration: Capable of contributing effectively to cross-functional teams, leveraging a diverse skill set to enhance project outcomes.

• Interpersonal Effectiveness: Demonstrates excellent interpersonal skills, fostering an efficient and constructive team environment, providing valuable feedback and coaching.

• Digital Proficiency: Skilled in utilizing a range of computer applications, including Microsoft Excel, PowerPoint, Word, Teams, and more.

Other Job Requirements

• Facilitate off-shift delivery of training as needed

• May be required to work weekends and off shift.

• Must be able to lift, push, pull and carry up to 50 lbs. 

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body as required.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• 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.

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 

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

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.

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Job Exempt