Title : Specialist, QA Operations
Location : Novato, CA
Duration : 3+ months
Industry : Pharmaceuticals
Description :
This position reports to the Quality Assurance Supervisor / Manager / Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in Novato manufacturing facilities.
The responsibilities in the role include the following :
- Provide quality oversight of one or more portions of operations including, but not limited to;
- Direct observation of manufacturing operation for adherence to GMP.
- Review of GMP documentation from manufacturing and / or QC, which can include log books, batch records and test records.
- Issuance of Production Batch Record to Manufacturing
- Scanning and archiving executed production batch records
- Ensure manufacturing and QC adherence to company policies / procedures, regulatory licenses, industry standards, and GMP regulations.
Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
Revise QA related procedures as needed.
Skills :
Attention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.
Education :
- Associate degree or higher.
Specialist, QA Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. The responsibilities in the role include the following: Provide quality oversight of one or more portions of operations includin...
Specialist, QA Operations
Provide quality oversight of one or more portions of operations including, but not limited to; Direct observation of manufacturing operation for adherence to GMP. Revise QA related procedures as needed. ...
Specialist, QA Operations
Provide quality oversight of one or more portions of operations including, but not limited to; Direct observation of manufacturing operation for adherence to GMP. Revise QA related procedures as needed. ...
Specialist, QA Operations
Title: Specialist, QA Operations. Provide quality oversight of one or more portions of operations including, but not limited to;. Revise QA related procedures as needed. ...
Field Operations Restoration, Manager
Electric Operations is responsible for every aspect of PG&E's electric distribution and transmission operations, including planning, engineering, maintenance and construction, asset management, business planning, restoration and emergency response. Job Category: Maintenance / Construction / Operatio...
Quality Assurance And Document Control Specialist
The Quality Assurance and Document Control Specialist is responsible for maintaining the highest standards of quality and reliability for Morse Micro's Wi-Fi HaLow integrated circuits (ICs) used in various applications. This role involves developing and implementing quality assurance protocols, work...
Project Management - Project Manager V Project Manager V
We are seeking an experienced Non-IT Project Manager to join our dynamic team focused on network deployment and infrastructure. Plan, direct, and coordinate activities related to network deployment and infrastructure projects. Oversee the integration of technical activities, analyze technology and r...
Quality Assurance Specialist
Quality Assurance Specialist 1. Bachelor's degree in life sciences with one year of relevant experience in a clinical or quality-oriented role, preferably in an FDA-regulated industry. ...
Data Analyst
Data Analyst will be responsible for helping build and maintain our master data. The Analyst will own cleaning and processing vendor catalogs on a regular basis and in a timely manner for a particular set of vendors, as well as processing data change request tickets. The Analyst will work with other...
Product Manager – Forecasting and Energy Portfolio Products
The Product Manager for Forecasting and Energy Portfolio Products will be part of Stem’s product management team and will own and extend forecasting and portfolio energy products and services at Stem. They will work with cross functional stakeholders and SMEs to ensure Stem continues to deliver indu...