26 Jul
US - Quality Assurance Expert
California, Carlsbad , 92008 Carlsbad USA

Vacancy expired!

Experis, a ManpowerGroup company has an exciting contract opportunity for an Quality Assurance Expert. This position is for one of our key clients, a global biopharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products.Please find below Job Description:

Job Role:

Quality Assurance Expert 1

Location:

Carlsbad, CA 92009

Duration:

12+ months (High Possibility of Extension).

Job Description:

The Quality Specialist will report to the QA Manager - Quality Systems. As a member of the Quality Assurance organization, you will be responsible for coordination and oversight of site Quality Systems.This role is an individual contributor position and requires the ability to independently manage timelines and effectively communicate with team member, cross-functional stakeholders, clients and external regulatory representatives. Additional responsibilities of this role may include:
  • Support the creation, execution, extension, and/or closure of site Deviations (Events), CAPAs and Change Management
  • Administration and data entry into site Learning Management System
  • Output cross-functional deliverables through meeting minutes
  • Administration of Client Communication activities, as needed, in relation to Deviations (Events) & Change Management
  • Support Measurement/Monitoring of Quality System data for submission of monthly metrics to Quality Management
  • Support Client Audits and Regulatory Inspections as needed

Basic Qualifications:
  • Bachelor's degree in a scientific discipline or related field.
  • Minimum 4 years of experience working within Quality in support of cGMP manufacturing or similarly regulated environment.
  • Change Control/Change Management Program experience
  • CAPA Program Management experience
  • Knowledge of Training requirements of cGMP manufacturing or similarly regulated environment
  • Understanding of Good Documentation Practices and Document/Records Controls
  • Ability to coordinate Quality System records and drive to completion
  • Experience supporting client audits and regulatory inspections
  • Organized and detailed oriented with strong and effective written and verbal skills
  • Strong interpersonal communication skills
  • Ability to work independently within prescribed guidelines, as well as collaboratively as part as part of a team
  • Proven ability to obtain direction and commitment to ensure that objectives are completed by due dates.

Preferred Qualifications:
  • Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals.
  • Change Control/Change Management Program experience.
  • CAPA Program Management experience.
  • CMO experience.
  • Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.

Primary Recruiter: Saira Hasan

Recruiter Phone Number: 414-666-8462 Ext - 7168

Recruiter Email:

Your LinkedIn (Link)

linkedin.com/in/saira-mohammad-hasan-28480211a

Vacancy expired!


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