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Job Title : Investigation Specialist
Location : Social Circle, GA
Applicants to this role will be responsible of managing investigations and Corrective/Preventive Actions (CAPA's) for manufacturing operations and accountable of timely closure investigational processes to support product release. Typical working hours: 8am to 5pm Monday through Friday. Additional working hours may be required as needed.
Lead Deviations/CAPA investigations
Collaborate with multiple cross functional teams (Quality, Engineering and Technical Service, etc.)
Manage complex investigations using DMAIC tools
Manage records workflow in Trackwise System
Author Investigation Reports
Stay current with biopharmaceutical industry best practices and technologies.
Organize data and preparing appropriate documentation, including presentation materials, for assigned projects
You will ensure implementation of corrective and preventive actions
Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls)
Implement improvement programs to improve yield, and process robustness. This may require leading and implementing change controls
You will demonstrate continuous improvement concerning increasing job knowledge and proficiency related to the biopharmaceutical industry, and technical understanding/ capability
Typically requires bachelor's degree in science, engineering or other related technical field. Some related experience preferred
Professional (GMP industry) experience ideal
Key Skills, Abilities, and Competencies
Have knowledge of core manufacturing principles and support systems
Previous work in a team-based environment preferred
Have experience using Excel (can maintain complex spreadsheets)
Strong Technical Writing
Ability to manage multiple priorities
Other Job Requirements
You may occasionally work in a clean-room environment and wear special garments
You may occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) because of safety requirements in specific areas. Company provides PPE.
You may be asked to work off-hours, extended periods of time occasionally
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.
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:
USA - GA - Social Circle - Hwy 278U.S. Base Salary Range:
$56,000.00 - $88,000.00The 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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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.
Job Exempt
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