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Software Quality and Systems Analyst II
67,900 - 106,700 USD
Takeda Pharmaceutical
Jasmine Parkway 505, SOCIAL CIRCLE
67,900 - 106,700 USD
Requirements
Must:
- I have a Bachelor's Degree in Computer Sciences, Engineering, or a related technical field with 2 years of experience.
- I possess at least 3 years of relevant experience in a GMP-regulated environment.
- I may hold appropriate additional certifications required under state or federal regulatory requirements.
- I have SQL and database knowledge, with experience in GMP regulated environments preferred.
- I have technical understanding and experience with computerized and automation platforms, such as LIMS, DeltaV, Honeywell, Rockwell PLC, or Siemens XFP.
- I have knowledge in ISA88, Batch Control.
- I possess at least 2 years of experience in laboratory software administration, including SQLLIMS, LabWare, MODA, Empower, and other QC instruments.
- I have strong technical problem-solving skills in regulated 21 CFR laboratory instrumentation and data integrity.
- I am proficient with Microsoft Word, Excel, PowerPoint, and Access.
- I can read and follow detailed written instructions and possess good verbal/written communication skills with supervisors, peers, vendors, and technical support.
- I will demonstrate effectiveness in my ability to train others.
- I am available to the network via remote connection after normal business hours.
- I can work in a team environment, collaborating with individuals at all organizational levels.
- I possess knowledge of industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
- I can solve routine problems effectively.
Responsibilities
- I will help maintain the LIMS, Empower, and other QC systems per 21 CFR requirements, which includes daily maintenance, account management, troubleshooting, and training.
- I will provide quality support related to computer systems on-site, including risk assessments, qualification documentation, data integrity, change control assessments, investigations, deviations, CAPA, and periodic reviews of computer system validations.
- I will administer all data groups, users, and permissions within the LIMS, Empower, and other QC systems.
- I will support troubleshooting of cross-instance configuration from other sites in the network and inbound and outbound LIMS communication with EBM systems.
- I will review and update software operational and administrative SOPs.
- I will provide and conduct training on LIMS.
- I will be involved in activities related to new instruments installed and communicated with LIMS and Empower.
- I will support validations and related documentation for new functionality and upgrades to any computer systems, including LIMS at the site.
- I will maintain data integrity, including performing assessments, periodic reviews, and disaster recovery following FDA guidelines and company SOPs.
- I will assist analysts in troubleshooting issues via remote connection after business hours.
- I will monitor/control the SQL LIMS Database and other QC instruments.
- I will provide technical subject matter expert (SME) support for authoring and reviewing Data Integrity Assessments, Risk Assessments, and Remediation Plans.
- I will provide regulatory and internal compliance guidance for computer systems commissioning, qualification, and validation activities.
- I will review and approve computer system-related validation documents and quality system records such as deviations, CAPA, and change control.
- I will participate in teams to determine the root cause and corrective actions for problems associated with investigations.
- I will perform, support, and review periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the systems.
- I will establish and enhance relationships between IT, Automation, Validation, and manufacturing units through collaboration and respectful challenge.
Description
At Takeda, our patients rely on us to deliver quality products. This means that I must follow strict rules in our manufacturing facilities to ensure we are not endangering product quality. I may be required to wear personal protective equipment (PPE) and cleanroom garments daily, such as safety shoes, safety glasses, aprons, face shields, lab coats, full-body gowns, hair nets, and gloves, as well as hearing protection. I will need to remove all makeup, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment and may work in cold, wet conditions. Additionally, I should be prepared to work multiple shifts, including weekends, or be asked to work supplemental hours, and work around chemicals like 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. As a certified Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace where our teams are united by a commitment to deliver Better Health and a Brighter Future to people around the world.
We understand that compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices. The U.S. base salary range for this position is $67,900.00 - $106,700.00, which may depend on various factors including qualifications, relevant experience, and location.
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