Job Details

ID #15726533
State California
City Pomona
Job type Contract
Salary USD TBD TBD
Source Manpower Engineering
Showed 2021-06-22
Date 2021-06-22
Deadline 2021-08-21
Category Science/biotech
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Sr. Project Manager, LIMS

California, Pomona, 91768 Pomona USA

Vacancy expired!

Sr. Project Manager, LIMS The LIMS Senior Project Manager provides project oversight and management for the design, development, implementation, maintenance, and support of the LIMS and is responsible for managing the entire project from start to finish, working closely with key departments including Quality Control, Quality Assurance, Engineering, and Compliance.

Essential Duties and Responsibilities include but are not limited to:

  • Serves as the primary point of contact for the Executive Leadership Team to report on program progress, resource needs and allocation, and communicates policy and governance gaps for timely decision by the responsible parties.
  • Functions as a resource to all functional areas of the LIMS support staff and works closely with division functional area leaders to allocate, manage, and monitor the progress of the LIMS program and related projects.
  • Manages deployment schedules, vendor, and customer relationships.
  • Develops and recommends solutions to resolve noted variances and works with the project team to successfully implement the accepted solution(s).
  • Identifies and resolves resource constraints, redundant / conflicting requests, and other related issues and is responsible for timely escalation of risks and problems that require assistance or intervention from upper management.
  • Review and approve LIMS data and related electronic documents to verify compliance with data integrity and 21 CFR Part 11 requirements.
  • Review and approve LIMS URS, PQ, and other related validation documentation.
  • Initiate change controls as necessary to facilitate LIMS functions.
  • Identify areas where LIMS training is needed and provide appropriate training as required to the site personnel.
  • Prepare and maintain LIMS related documents for Quality Control Department.
  • Improve self-awareness and site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.

Knowledge/Skills/Abilities

  • Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices (cGMP), FDA, DEA and other legislation regulating the production operation.
  • Proficient in use of LIMS related software, with demonstrated LIMS implementation experience.
  • PC proficiency using lab related software, statistical software as well as Microsoft Office.
  • Outstanding oral communication and conflict resolution skills with all levels of the organization.
  • Ability to think critically and apply critical thinking processes to data reliability investigations.
  • Highly organized and able to work comfortably with accelerated work pace.

Education/Experience

  • Bachelor's degree in the sciences or related technical field required.
  • Minimum five years' experience in project management role involving LIMS applications; i.e. URS, template building, user testing, specifications, and routing LIMS maintenance in a pharmaceutical or other highly regulated environment required.
  • A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.

Vacancy expired!

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