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Job Description About the role: You will help maintain the LIMS, Empower and other QC systems, per 21 CFR requirements, including daily maintenance, account management, troubleshooting and training.
Additionally, you will provide quality support relative to computer systems on site, including risk assessments, qualification documentation, data integrity, change control assessments, investigations, deviations, CAPA and periodic review of computer system validations. You will report to the QA Computer System Administrator Manager in Social Circle, GA.
How you will contribute:
- Administer all datagroups, users and permissions within the LIMS, Empower and other QC system.
- Support troubleshooting of cross instance configuration from other sites in the network and inbound and outbound LIMS communication with EBM systems.
- Review and update software operational and administrative SOP's.
- Provide and conduct training on LIMS.
- Involve in activities related to new instruments that will be installed and will be communicated with LIMS and Empower.
- Support on validation's and related documentation for new functionality and upgrades to any computer systems including LIMS at the site.
- Maintain data integrity, including performing assessments, periodic reviews and disaster recovery per FDA guidelines and company SOP's.
- Assist analysts in troubleshooting issues via remote connection after business hours.
- Monitoring/Control of the SQL LIMS Database, and other QC instruments.
- Provide technical subject matter expert (SME) support for authoring and reviewing Data Integrity Assessments, Risk Assessments, and Remediation Plans.
- Provide regulatory and internal compliance guidance for computer systems commissioning, qualification and validation activities.
- Review and approve computer system related validation documents and quality system records such as deviations, CAPA, and change control.
- Participate on teams to determine the root cause and corrective actions for problems associated with investigations.
- Perform, support and review periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the systems.
- Establish and enhance the relationships between IT, Automation, Validation, manufacturing units through collaboration, respectful challenge, and ability to support QA decisions.
- Participate in audits and regulatory agency inspections as a representative of QA Systems.
- Excellent analytical skills with systematic approaches to problem solving. Will break down complex problems and tasks into manageable activities.
- Knowledge in basic principles in automation and computer systems.
- Identify when proper practices/ procedures are not performed.
- Be a support function to site operations and is required to coordinate activities and communication with IG, Fractionation, and Albumin. Also, you will also correspond with other support departments such as QA, EBM, Engineering, Maintenance. You should work with different disciplines in Takeda to support data integrity, commissioning and qualification activities for any computer systems. You may participate in interdepartmental teams and communicate with different levels of personnel including management, site leadership and global.
What You Bring to Takeda:
- Bachelor's Degree in Computer Sciences, Engineering or other related technical field with 2+ years of experience.
- 3 years of relevant experience in a GMP regulated environment required.
- Appropriate additional certifications may be required under state or federal regulatory requirements.
- SQL and database knowledge.
- Relevant experience in GMP regulated environment preferred.
- Technical understating and experience computerized and automation platform, such as LIMs, DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
- Knowledge in ISA88, Batch Control
- At least 2 years' experience in laboratory software administration, including SQL LIMS, LabWare, MODA, Empower and others QC instruments.
- Technical problem-solving skills in the area of regulated 21 CFR laboratory instrumentation and data integrity.
- Experience with Microsoft Word, Excel, Power Point Access.
- Can read and follow detailed written instructions and have good verbal/written communication skills with supervisors, peers, vendors and technical support.
- Must Demonstrate effectiveness in ability to train others.
- Availability to the network via remote connection after normal business hours and required.
- Work in a team environment, working with individuals at all levels in an organization and departmental areas.
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
- Can solve routine problems.
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. You may:
- May 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 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,.
- 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 to 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.
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: 67 700.00
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 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.
LocationsUSA - GA - Social Circle - Hwy 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes
