Hybrid IT Business Process Analyst

at Teva Pharmaceuticals

• Job title: IT Business Process Analyst
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform, SDLC
• Location requirements: Hybrid, West Chester, United States

About the role

• IT Business Process Analyst supporting the implementation and maintenance of laboratory systems at Teva Pharmaceuticals in West Chester, PA. Collaborating with teams and ensuring compliance with regulations.

Responsibilities

• Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within the pharmaceutical laboratory research and development organization.
• Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
• Collaborate with laboratory business, staff, IT colleagues, vendors, and other stakeholders to support existing processes and technologies.
• Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
• Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
• Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
• Perform PC/System specification configuration according to vendor requirements, works with IT Operations for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.
• Liaise with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
• Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems.
• Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
• Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems.
• To be the site expert on all laboratory computer systems – LIMS (Labware), LIMS (Watson LIMS), IDBS Polar, CDS (Empower), standard-alone computer driven instrumentation and other applications identified by laboratory management.
• Remotely support other Teva sites across multiple zones as needed.

Requirements

• Minimum 3 years of experience working in a validation analyst or similar role, preferably within the pharmaceutical industry.
• Minimum 6 years of experience working as a validation analyst is preferred.
• Extensive experience in regulated biotech, pharmaceutical, medical device, cosmetics, or food companies.
• Experience in regulated environment (GLP, GCP or GMP).
• Experience in 21 CFR Part 11, GAMP.
• Experience in SDLC (Agile or Waterfall).
• Experience in providing face-to-face and remote business analyst support to laboratory system users in a highly regulated environment within the Pharmaceutical Industry.
• Successful experience working in a team environment and with a multi-disciplinary and global team.
• Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.
• Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
• Excellent verbal and written English communication skills.
• Knowledge of laboratory technical configurations.
• Knowledge of installation of system software and tools.
• Knowledge of workflows in the laboratory space.
• Excellent Organizational Skills - ability to manage time and multiple tasks.
• Strong problem-solving skills.
• May have specialized external certification.
• Has developed proficiency in a range of IT processes or procedures through job-related training and considerable on-the-job experience in a laboratory environment.

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.