QA Computer System Admin II - Takeda

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Job Description
About the role:
You will assist in maintaining the LIMS, Empower, and other QC systems in compliance with 21 CFR requirements, including daily maintenance, account management, troubleshooting, and training.
Additionally, you will provide quality support for on-site computer systems, including risk assessments, qualification documentation, data integrity, change control assessments, investigations, deviations, CAPA, and periodic reviews 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 LIMS, Empower, and other QC systems.
• Support troubleshooting of cross-instance configurations and LIMS communication with EBM systems.
• Review and update software operational and administrative SOPs.
• Conduct training on LIMS.
• Participate in activities related to new instruments integrated with LIMS and Empower.
• Assist with validations and documentation for new functionalities and upgrades.
• Ensure data integrity through assessments, periodic reviews, and disaster recovery.
• Help analysts troubleshoot issues remotely after hours.
• Monitor the SQL LIMS Database and other QC instruments.
• Provide SME support for Data Integrity Assessments and Risk Assessments.
• Guide regulatory compliance for computer systems commissioning and validation.
• Review and approve validation documents and quality system records.
• Participate in root cause analysis for investigations.
• Conduct periodic reviews of qualifications and validations.
• Foster collaboration between IT, Automation, Validation, and manufacturing units.
• Represent QA Systems during audits and inspections.
• Demonstrate strong analytical and problem-solving skills.
• Identify non-compliance with practices/procedures.
• Coordinate activities with various departments to support data integrity and qualification activities.

What You Bring to Takeda:

• Bachelor's Degree in Computer Sciences, Engineering, or related field with 2+ years of experience.
• 3 years of relevant experience in a GMP regulated environment.
• SQL and database knowledge.
• Experience with laboratory software administration, including SQL LIMS and Empower.
• Technical problem-solving skills in regulated laboratory instrumentation.
• Familiarity with industry guidelines and regulations for GMP environments.
• Ability to work in a team and communicate effectively across levels.

Important Considerations:
At Takeda, we prioritize product quality and adhere to strict manufacturing rules. You may:

• Wear personal protective equipment (PPE) and clean room garments.
• Remove makeup, jewelry, and artificial nails in the manufacturing environment.
• Work in a cold, wet environment and multiple shifts, including weekends.
• Handle chemicals requiring respiratory protection.

More About Us:
At Takeda, we are dedicated to transforming patient care through innovative pharmaceuticals and support programs. We are a certified Global Top Employer, fostering an inclusive workplace committed to delivering Better Health and a Brighter Future.
Takeda Compensation and Benefits Summary
We are committed to equitable pay and transparency in our compensation practices.
Location: USA - GA - Social Circle - Hwy 278
U.S. Base Salary Range: $67,700.00
The actual salary may vary based on qualifications, experience, and location.
U.S. employees may be eligible for various benefits, including medical, dental, vision insurance, 401(k) plans, and paid time off.
EEO Statement
Takeda is committed to diversity and equal employment opportunities for all individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or 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