Manufacturing Process Technician
Thousand Oaks, California
Posted on: November 8, 2019
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -112019-50258
- Analytical testing, characterization, sample and data management
- Equipment maintenance
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within the team.
- Support manual visual inspection of filled units
Specific Job Duties:
- Plan and perform routine analyses with efficiency and accuracy.
- Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
- May perform aseptic aliquoting, sampling and analysis of compendia methods
- Prepare complete and accurate laboratory documentation following GMP guidelines.
- With a high degree of technical flexibility, work across diverse areas within the lab.
- Evaluate analytical data
- Perform general lab housekeeping
- Maintain/operate specialized equipment
- Comply with safety guidelines, GMPs and other applicable regulatory requirements
- Initiate and/or implement changes in controlled documents
- Troubleshoot, solve problems and communicate with stakeholders
- Participate in audits, initiatives, and projects that may de departmental or organizational in scope
- Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
- May participate in lab/inspection investigations
- May provide technical guidance
- May train others
- May contribute to regulatory filings
- May represent the department/organization on various teams
- May interact with outside resources
- Support manual visual inspection of drug product filled units
- Deepens technical knowledge trough exposure and continuous learning
- Bachelor’s Degree in Life Sciences & minimum 2 years of biopharma industry QC experience or related quality control or GMP laboratory experience
- Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
- Filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system; basic GMP knowledge
- Experience in GMP facility; Ability to perform tasks following standard operating procedures, protocols, and/or test plans comfort with electronic control systems (Delta V, MES)
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