Associate, QA Frontline (Night Shift)

About Technical 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. 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.

TITLE

Associate, QA Frontline

Summary

The QA Frontline team is committed to providing real time QA support to the manufacturing facilities by performing on the floor batch record review and responding to quality-related events.

Responsibilities

• Provide on the floor QA oversight and support to manufacturing operations
• Review executed batch records and associated documents to ensure compliance with 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
  
  

Experience

Required Skills:

• 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
  
  

Desired Skills:

• At least 2+ years of experience in the Biopharmaceutical industry
• Manufacturing and Manufacturing Sciences experience preferred
  
  

EDUCATION

B.S. in scientific discipline or equivalent work experience

EQUIPMENT

Computers, printers, scanners

CONTACTS

Manufacturing teams

Quality

SHIFT DETAILS

Alternating Saturdays, Sunday – Tuesday 1800-0700

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.

ONSITE, REMOTE, OR FLEXIBLE

Onsite

Travel Required

None

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

The salary range for this position is: $77,800 to $116,600. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.