Quality Systems Specialist in Camarillo, CA at Volt

Date Posted: 3/24/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Camarillo, CA
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    3/24/2020
  • Job ID:
    188126
  • Contact Name
    Volt Branch
  • Phone
    805/560-8658

Job Description

We have an excellent permanent opportunity for a Quality Systems Specialist. You need to have 3 to 5 years’ experience in pharmaceutical operations, to be considered. Don’t miss this opportunity “Apply Now” to sweslander@volt.com.

Summary:

 Under the direction of the Manager of Quality Systems, the Quality System Specialist ensures compliance with Quality System requirements.  The Quality System Specialist works collaboratively with personnel from other functional areas, such as, Packaging, Compliance, Procurement, Business Development, and Sales, in providing leadership for the development, maintenance, and continuous improvement of Quality System program and processes throughout GSMS.  This includes, but is not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, CAPA Program, which includes the Deviation, Corrective Action and Preventive Action (CAPA). 

General Duties and Responsibilities: 

Responsibilities may include the following and other duties may be assigned. 

  • Leads the development, maintenance and continuous improvement of quality programs, processes and procedures.
  • Responsible for interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Ensures Quality System policies, procedures and performance conform to regulatory requirements, standards, and guidelines.
  • Owns and leads quality system processes performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA)
  • Works directly with internal and external suppliers and customers to ensure quality system requirements are met.
  • Performs internal audits and inspections, including writing of audit report and presenting to upper management. Responsible for adherence to audit timelines and reporting.  
  • Assists with external audits of suppliers as needed.
  • Responsible for managing customer and regulatory audits and inspections, including audit/inspection response and tracking.
  • Leads recall related activities for customer communication, product returns and FDA reporting.
  • Prepares and presents quality system performance reports to senior management.

 Experience:

Minimum 3-5 years in pharmaceutical operations required. Bachelor’s degree preferred. 

Internal auditing experience a plus.

ZIP2019P