Senior Specialist/Specialist, Quality Systems

MEI Pharma, Inc San Diego, CA
senior quality systems management management system training qa document management mei deviations gxp communication cancer patients
December 5, 2022
MEI Pharma, Inc
San Diego, CA
OTHER

Job Summary:

MEI Pharma is a clinical-stage pharmaceutical company committed to the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients. Our approach is to fully understand and leverage the mechanisms and properties of our drug candidates to optimize the balance between efficacy and tolerability to best meet the needs of patients with cancer.

Reporting to the Manager, Quality Systems, the Specialist/Senior Specialist, Quality Systems will work closely with the QA group. This position requires various clerical skills to support the Document Control and Training functions and help maintain and support a company-wide Electronic Document Management System (EDMS) and Learning Management System (LMS) called MasterControl. Additionally, this position will also assist in supporting various Quality Management System (QMS) functions such as Deviations, Change Control and CAPA.

Role and Responsibilities (Include but not limited to):

  • Acts as the administrator of the Document Change Management function in MEI’s Electronic Document Management System (MasterControl) to support Pharmaceutical Services and other functional areas
  • Acts as the administrator of the Learning Management System (Training Module) in MEI’s Electronic Document Management System (MasterControl) to create and maintain training files for all GxP employees (e.g., deploy Job Codes and initiate courses)
  • Responsible for managing on-boarding of GxP new hires
  • Responsible for maintaining the flow of both electronic and hard-copied controlled documents, department files, and resource materials
  • Coordinating document control issues between internal and external groups and preparing reports regarding quality issues
  • Recognize problems, recommend solutions, and put the solutions into action. Maintain confidentiality as they interact with all levels of an organization
  • Complete projects (including system enhancements) in a timely manner
  • Responsible for maintaining numerous quality system logs as defined per project
  • Provides clerical and administrative support related to documentation processes and systems (SOP formatting, InfoCard Title in MasterControl and more)
  • Assist the QA group in various tasks related to coordination of GXP training (GCP and GMP Training)
  • Reviews change request in MasterControl
  • Reviews and approves Deviations, Change Control and CAPAs
  • Assist with QA initiatives/projects to implement process improvements
  • Other duties as directed by QA management

Qualifications:

  • Working knowledge of cGMPs and FDA regulations as it pertains to document control
  • Excellent written and verbal communication skills
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute department activities
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines
  • Ability to adapt quickly to changing policies and procedures
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight
  • Knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research
  • Demonstrates professionalism and presents a positive image of the department
  • Demonstrates excellent time management skills by prioritizing time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability, and flexibility with changes in responsibilities and duties
  • Demonstrates honesty and integrity in dealing with others, works effectively with different types of people and accepts constructive feedback without becoming defensive
  • Seeks input from others when faced with a difficult situation, makes sound decisions within the scope of responsibility, and focuses on resolving problems rather than placing blame
  • Establishes and maintains effective relationships with customers both internal and external and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high level of energy when interacting with customers and acts with the customer in mind.

Job Requirements and Education:

  • Bachelor’s degree in a scientific/technical discipline
  • Seven years (or plus) pharmaceutical or biotech experience
  • Experience with an electronic document management system or equivalent (MasterControl experience a plus)
  • Experience in MS Office product (Excel, PowerPoint & Word)
  • Experience in Adobe
  • Experience working in Document Control or in a regulated environment setting a plus
  • Self-directed nature, ability to work independently with minimal supervision, and ability to follow directions
  • Self-motivated and able to organize and prioritize multiple tasks
  • Excellent interpersonal, verbal, and written communication skill
  • Experience with QMS, and validated software is a plus.
  • Experience with Quality Events (Deviations, Change Control and CAPA)

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting up to 25 lbs
  • Routine office duties including computer keyboard use
  • Vision requirements include close vision and ability to focus
  • Noise conditions range from quiet to moderate

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