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The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. He/She initiates new documents for procedures which are simple in nature and may also make minor revisions to existing documents. The incumbent can troubleshoot simple existing procedures. He/She may demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers.
Prepare media and buffer solutions.
Operate Clean-in-Place (CIP) and Steam-in-Place systems. Assemble and operate filtration systems.
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
Monitor and record critical process parameters.
Complete all relevant paperwork following GDP/GMP guidelines.
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
Perform sampling using aseptic techniques. Participate on Continuous Improvement Teams.
Receive and distribute supplies into production areas as necessary. Train and mentor other team members.
Revise and review pertinent documentation as appropriate.
Assist in troubleshooting process problems and responding to alarms. May perform other duties as assigned.
Typically requires high school diploma or GED plus 1+ years of related experience or or higher with no prior experience required.
Knowledge of cGMP manufacturing
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement
Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
Knowledge of basic chemical and biological safety procedures. Good computer skills, knowledge of Microsoft Word and Excel.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
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.
2-2-3 Rotating Day Shift (6:00 AM – 6:30 PM) | Includes weekends, some holidays, and required overtime.
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.
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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. Hourly Wage Range:
$16.15 - $25.38The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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.
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