QA Operations Specialist
BioSpace
Date: 2 weeks ago
City: Novato, CA
Contract type: Full time
Who We Are
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. 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 coordinating the worldwide movement of our drugs to patients.
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.
SkillsAttention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.EducationAssociate degree or higher.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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. 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 coordinating the worldwide movement of our drugs to patients.
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.
SkillsAttention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.EducationAssociate degree or higher.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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