- Provide on the floor QA oversight and support to manufacturing operations
- Review executed batch records and associated document 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 Manufacturing Sciences and Technology (MSAT) personnel
- Provide QA support including write, review, and approve documents in Quality Management Systems in accordance with BioMarin policies
- Perform area walkthroughs
- Perform other duties and projects as assigned by management
- BS/BA in a scientific discipline or related field and 6 8 years experience in a biologics manufacturing environment
- Prior batch record review experience is required
- 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 MSAT experience preferred
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Sr. Associate, Quality - Novato, United States - Biomarin
Description
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.
Senior Associate, Quality – On-Site Day ShiftResponsibilities:
Experience and Other Qualifications:
Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibilityis required, as shift hours canvarydepending on operational demands.
Shift Details:
Alternate Wed, Thurs-Sat
We do provide Shift Differential pay for any off-hour shifts including Swing and Grave
No international travelling required.
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.
In the U.S., the salary range for this position is $ 93,200 to $ 139,800 per year, which factors in various geographic regions.
The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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