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GMP Compliance Manufacturing Manager

GMP Compliance Manufacturing Manager

Takeda PharmaceuticalUS
2 days ago
Job type
  • Full-time
Job description

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 Takedas 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.

Job Description

About the Role :

The supervisor position implements and supervises daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May manage labor resources.

How you will Contribute :

  • Oversee the daily manufacturing operations in an area. Maintain (audit, refine, improve) equipment and processes within this area.
  • Provide a positive and equitable working environment emphasizing respect, responsiveness and results.
  • Support and emphasize the Safety and Quality commitments of the department. Make decisions concerning these commitments within the area.
  • Use resources and raw materials in the most efficient and productive manner possible.
  • Identify resources in an area to assist the superintendent to meet the annual operational plan and budgetary commitments.
  • Facilitate and verify appropriate training for employees in the area (including GMP, job skills, safety).
  • Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements.
  • Commit to employee feedback and developmental process support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.
  • Submit and maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others.
  • Utilize resources and raw materials in the most efficient and productive manner possible.

What you bring to Takeda :

  • Typically requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience with 1+ years in a supervisor role.
  • Work with well with other departments and lead in a team environment.
  • Experience preparing technical reports.
  • Understand GMPs and other regulatory guidelines applicable to the medical / pharmaceutical industry.
  • Work with all levels of personnel manufacturing, Quality, documentation, and personnel issues.)
  • Collect and analyze data and information to determine paths for process improvement and potential root cause / corrective actions in the case of exceptions.
  • 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 :

  • Must be able to carry up to 25 lbs., lift up to 50 lbs., and push / pull >
  • 100 lbs. (with the assistance of material handling equipment).

  • Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
  • Must be able to climb ladders and stairs while wearing special gowning.
  • May require bending, twisting, reaching overhead, and / or squatting motions to perform certain tasks.
  • 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.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment.
  • Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
  • May be required to work in a confined area.
  • Some Clean Room and cool / hot storage conditions.
  • May require immunization before performing work within the manufacturing area
  • 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 #LI-Onsite

    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 :

    USA - GA - Social Circle - Hwy 278

    U.S. Base Salary Range :

    $86,500.00 - $135,960.00

    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.

    U.S. based employees may be eligible for short-term and / or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    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.

    Locations

    USA - GA - Social Circle - Hwy 278

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Job Exempt

    Yes

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