- Work in a dynamic production environment atsite supporting development, clinical, and launch activities.
- Under general supervision, employee will perform operations in the Manufacturing area.
- Operations will be performed according to Standard Operating Procedures (SOPs).
- Performing in-process sampling of equipment and operating analytical equipment
- Performing washroom activities: clean small- and large-scale equipment used in production activities.
- Maintaining an organized and clean workspace
- Initiating quality reports
- Drafting and revising documents (SOPs, MPs)
- Assisting in the review of documentation for assigned functions (equipment logs, batch records)
- Bachelor's Degree in Biology and/or Life Sciences.
- Mechanically inclined (understanding of repairs, etc.)
- Experience in Set-up, cleaning, and sanitization of various manufacturing equipment
- Experience in preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
- Knowledge ofGMP documents (SOPs, MPs) with strict adherence to safety and compliance
- Able to workin a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work.
- Must be able to work all shifts
- Must be able to understand GMP and compliance
- Shift is either Sunday-Weds or Weds-Saturday (4x10)
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Manufacturing Associate I - Thousand Oaks, United States - Quality Consulting Group, LLC
Description
QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications: