May collaborate with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups in support of Quality Record investigations/closure. Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
Numbers & Facts
Location
Newark, CA
Description
Our Client, an Aesthetics and Skincare Solutions company, is looking for a Manufacturing Associate for their Newark, CA location.
Responsibilities:
Operate in a controlled GMP environment.
Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.).
Ensure compliance with established internal and external control procedures.
Participates in the execution of Drug Product activities to support the production/manufacturing schedule.
Demonstrates operational proficiency in Drug Product-related process equipment, as required per business needs.
Initiate and supports the closure of Deviation Reports.
Supports the initiation and closure of CAPA and CR Tasks as required per business needs.
Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
Responsible for revising and originating production records, standard operating procedures, protocols and reports.
Supports the ongoing continuous improvement within the Drug Manufacturing Process.
May collaborate with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups in support of Quality Record investigations/closure.
Requirements:
Required: 0-3 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.
Preferred:
Hands-on skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).
Hands-on skills with aseptic fill finish operation. Hands-on experience with automated filling/capping machine, and Lyophilizer.