QA Frontline Associate

7 days ago


Novato, California, United States inSync Staffing Full time

QA Frontline Associate
100% Onsite
Alternate Wed, Thurs-Sat 06:00-8:00pm
Pay Range: $35.00 - $42.50

-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 BioMarin policies
-Perform area walkthroughs
-Perform other duties and projects as assigned by management
Please note that while this role primarily involves day 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

B.S. in scientific discipline or equivalent work experience.

Benefits:

• Health insurance

• Health savings account

• Dental insurance

• Vision insurance

• Flexible spending accounts

• Life insurance

• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act



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