What are the responsibilities and job description for the Senior Quality Assurance and Data Integrity Specialist position at Takeda Pharmaceutical?
About Us
Takeda Pharmaceutical is a leading global pharmaceutical company committed to transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our mission is to deliver Better Health and a Brighter Future to people around the world.
Job Summary
We are seeking an experienced Senior Quality Assurance and Data Integrity Specialist to join our team in Social Circle, GA. As a key member of our QA department, you will be responsible for maintaining the integrity of our laboratory data and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Maintain the Laboratory Information Management System (LIMS), Empower, and other QC systems per 21 CFR requirements
- 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
- 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
- Support 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
Requirements:
- Bachelor's Degree in Computer Sciences, Engineering, or other related technical field
- At least 2 years of 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, PowerPoint, Access, and SQL
- Good verbal and written communication skills
- Availability to work multiple shifts, including weekends, and supplemental hours
What We Offer:
- A competitive salary and benefits package
- The opportunity to work with a global leader in the pharmaceutical industry
- A collaborative and inclusive work environment
