Job Description
Position Title : Associate, QA Frontline (Overnight)
Location : Novato, CA
Duration : 12 Months Contract on w2
Shift Details :
Alternate Wed, Thurs-Sat 6 : 00 PM 7 : 00 AM
Alternate Wed, Sun-Tues 6 : 00 PM 7 : 00 AM
Duties :
- Provide on-the-floor QA oversight and support to manufacturing operations
- Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations
- Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
- Represent QA in support of deviations including active participation in Root Cause Analysis (RCA)
- Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel
- Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with policies
- Perform area walkthroughs
- Perform other duties and projects as assigned by management
Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.
- Prior batch record execution or review experience
- Prior experience in investigation, change control, other Quality Management Systems (QMS)
- Working knowledge of cGMPs
- Excellent written and verbal communication and interpersonal skills
- Must display strong analytical and problem-solving skills
- Manufacturing and Manufacturing Sciences experience preferred
Manufacturing Supervisor
Manufacturing and Manufacturing Sciences experience preferred. Provide on-the-floor QA oversight and support to manufacturing operations. Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel. ...
Senior Manufacturing Supervisor
The Senior Manufacturing Supervisor will oversee Catheter Manufacturing Operations. Lead and supervise a team of Product Builders, ensuring adherence to standard operating procedures (SOPs), Manufacturing Process Instructions (MPIs) and safety protocols. Implement lean manufacturing principles and c...
Supervisor, Manufacturing (Grave Shift)
These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordi...
Manufacturing Supervisor
Saxon Aerospace is currently hiring a 2nd Shift Manufacturing Supervisor for a growing manufacturing company in the greater Los Angeles area. As the Manufacturing Supervisor, you will be responsible for leading the team in all phases of machine shop operations including production, quality control, ...
Maintenance Supervisor - Food Manufacturing
We are seeking a skilled Maintenance Supervisor to oversee the maintenance operations of our facility and ensure that all machinery and equipment are functioning efficiently and effectively. ...
Manufacturing Science and Technology Manager
Manufacturing Scientist and Technology Manager,. This role is on the Site Leadership Team, reporting to the Plant Manager. In this role, you will be key to safely and efficiently meeting the current and future manufacturing commitments for a growing, key business for Bio-Rad. In this role, you, and ...
Ad Operations Supervisor
Develop plans to optimize ad operations processes and workflows. Experience working within digital advertising operations. ...
Manufacturing Manager
The Manufacturing Manager will oversee the manufacturing operations for our Class III medical devices, ensuring that all processes comply with regulatory standards and company policies. This role requires a strong leader with extensive experience in manufacturing, quality assurance, and process opti...
Production Manager
Join our team as a Production Manager and take charge of overseeing production activities across three key departments, including machine shop operations and specialized processes (welding, brazing, painting, and varnishing). Production Manager – Lead Operations Across Multiple Departments!. Ensure ...
Senior Manufacturing Engineer - Catheters
A contract manufacturing client looking for a direct hire Senior Manufacturing Engineer in Santa Clara, CA who can bring innovation and creative thinking to the team on catheter-based devices. As a Senior Manufacturing Engineer, you will be primarily responsible for maintaining, developing, and impl...