Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

Multiple regulations from the FDA and other governmental health authorities require that Millennium's use of electronic records, computerized systems and computerized or automated lab equipment meet certain specifications for reliability and data integrity. The Computer & Lab Systems QA Unit (CLS QA) establishes policy, procedure and oversees the validation of all GxP computerized systems in use at Millennium.
Through collaboratively participating on projects to implement, upgrade, enhance, modify or otherwise change computerized systems, the CLS QA Specialist ensures that MPI's requirements for validation are met and that all electronic records and the systems that create them are operating properly.

This role will report to the Manager of CLS QA Department.

Duties and Responsibilities:

* Participate as assigned QA representative on project teams to design, implement and validate enterprise class GxP computerized systems.

* Participate as assigned QA Representative on project teams to implement and validate computerized or automated Lab Instrumentation and associated computer hardware and software.

* Review and/or approve the following as assigned: Written procedures (SOP's, PG's, WP's, etc) that are part of the Computer and Lab Systems Quality System or otherwise impact Millenniums GxP use of computerized systems; equipment related procedures, specifications, and other documents that may affect the GXP compliance of equipment used to support GXP testing at MPI; validation documentation created in performance of SOPs that are part of the Computer and Lab Systems Quality System; deviations from or corrective actions for any part of the Computer and Lab Systems Quality System based on written justification and cross functional review of impacted parties.

* Review and approval of exceptions to approved procedures and project specific protocols (e.g. Test Variances, CAPA, CAR, etc.).

* Support the audit or inspection of any vendors or partner organizations relative to their creation of computer system products, use of computerized systems, or calibration, preventive maintenance and equipment qualification service, as assigned by management.

* Maintain sufficient expertise in IT System Lifecycle, IT Project Management, Validation plus one or more other QA disciplines to independently perform analysis and draw appropriate conclusions.

Qualifications:

BASIC QUALIFICATIONS

Bachelors degree. 2 years of experience in the Pharmaceutical or Life Sciences industry supporting validated computer systems.

PREFERRED QUALIFICATIONS

Bachelors of Science in MIS, Engineering or other related scientific field
Strong knowledge of US FDA & International Regulation of Computerized Systems
3-5 Years of System Design & Implementation Experience
3-5 Years of System Validation Experience