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Quality Specialist, Manufacturing

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients’ lives. 

Quality Specialist, MFG

SUMMARY
The successful candidate will be a key contributor of the team to design and implement a FVIII Gene Therapy production area and in development of a new Gene Therapy product. 

The Manufacturing Quality Specialist is responsible for expertise in Trackwise and initiating, investigating and writing Manufacturing Deviations, CAPAs and Effectiveness Checks.  These may include Minor to Major scope deviations and also includes Quality Events and Material Incidents.  The Manufacturing Quality Specialist is responsible for being a Subject Matter Expert in these systems, and acting as a coach for others in Manufacturing.  The Manufacturing Quality Specialist may also lead internal audits and assist in regulatory inspections and co-own Regulatory Observations. The Quality Specialist will also be a project lead on multiple complex changes within commercial manufacturing.   This role may apply to any aspect of the manufacturing process, including Media/Buffer Prep, Cell Culture, Purification and Fill Finish operations.  This position involves frequent interaction with many cross-functional departments in Technical Operations.  Other responsibilities include coordination of training and regular technical evaluation of processes and procedures to ensure optimal operations and performance.

Additional responsibilities include ownership and implementation of CAPAs and helping to ensure timely closure of Deviations & CAPAs for the overall department. The MFG Quality Specialist will also play an active role in internal audits and regulatory inspections.  Other responsibilities include coordination of training, leading and regular technical evaluation of all processes and procedures to ensure optimal operations and performance.  This position requires advanced skills in technical writing and project management.  

RESPONSIBILITIES

Essential Functions:

  • Provide a fundamental leadership role and act as a SME & coach as needed for the following responsibilities:
  • Leadership Roles:
  • He or she will provide advanced expertise in Trackwise and taking a leadership role in investigating and writing Manufacturing Deviations, CAPAs and Effectiveness Checks. The MFG Quality Specialist will assist in developing others as Subject Matter Experts.
  • MFG Quality Specialist will focus on future improvements and the ability to strategically plan for future Quality & Compliance Systems changes to meet future changes in Technical Operations.
  • The MFG Quality Specialist will also have direct oversight and involvement of GMP Facility cleaning operations and gowning management.
  • Involvement may include but is not limited to participating in cleaning audits, review of cleaning forms and coordination of cleaning activities.
  • Lead investigations & ownership of Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise.
  • Timely closure (within 30 days for Deviations, QEs) is a critical aspect of this responsibility.
  • The MFG Quality Specialist will also act as a coordinator for other deviations within the department, to take a larger role for department compliance.
  • Ensure timely Material Holds and Impact Assessments during investigations.
  • Investigate deviations; work with cross-functional groups to complete deviation reports and close incidents in a timely manner.
  • Investigations should be thorough, with meaningful CAPAs.
  • Meet due dates for CAPA closures and lead others to meet due dates.
  • Provide training as needed to support above efforts.
  • A MFG Quality Specialist will be able to act as a Compliance SME.
  • Managing Change Requests (CRs).
  • Work with Manufacturing staff and QA Change Control to develop comprehensive implementation plans for CRs.
  • Maintain tracking of CRs and document changes within the department.
  • Participate in regular meetings with cross functional groups, including Quality Assurance and Manufacturing Sciences, to initiate and coordinate changes to processes and equipment.
  • Identify and facilitate improvements to the CR process with respect to Manufacturing inputs.
  • Training responsibilities
  • Responsible to complete all training on time.
  • Work with Manufacturing supervisors and managers to ensure cGMP compliance with respect to training of manufacturing staff.
  • Help to identify, implement and lead key improvements in Technical Training as needed.
  • Lead training efforts and assist in developing training content as needed.
  • Process Improvement
  • The MFG Quality Associate will identify process improvements and assist with implementation of improvements for all systems in which he or she works. This includes MFG processes, as well as Trackwise.
  • Advanced understanding of Regulatory Policies and cGMP; teach and coach others in leadership roles for cGMP policies and help to improve and lead positive improvements in cGMP behaviors and procedures.
  • Acquire advanced knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification, Fill Finish operations.
  • Comply with cGMP Documentation & Operations
  • Record information accurately and honestly.
  • Make corrections in a timely manner.
  • Ensure all entries are neat and legible.
  • Understand perform and verify responsibilities.
  • Understand, observe, and practice proper gowning.
  • Understand flow of materials and personnel in the manufacturing areas.
  • Compliance with 21 CFR - Parts 210 and 211.
  • Compliance with safety guidelines
  • Use safety eyewear and footwear while inside a manufacturing area.
  • Know appropriate emergency response procedures.
  • Know locations of first aid kits, safety showers, and spill kits.
  • Know evacuation route and assembly area to be used in case of fire or earthquake.  
  • EXPERIENCE
  • “3+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency at validation and/or change control (with BA or BS in biological science or engineering).
  • Experience with active roles during Audits or Regulatory Inspections.
  • Technical writing must be at an advanced level with proficient spelling, grammar, and typing skills preferred.  Ability to understand and teach special writing skills for impact assessment and minimizing risk of language.
  • Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including BioMarin Management or inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Organizational skills to contribute to cross-functional projects.
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.  Experience and proficiency with other applications including Trackwise, CMMS, LIMS, SCADA etc.
  • Advanced understanding of change control and related FDA & European.  
  • EDUCATION
  • BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 6+ years related to pharmaceutical manufacturing.
  • MS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing.
  • EQUIPMENT
  • This position requires ability to utilize a computer to perform tasks, including report generation.
  • Ability to perform gown activities and enter the manufacturing plant is required.  
  • CONTACTS
  • This position will require interaction with multiple levels (from employees up to Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Support, Facilities, Engineering, Regulatory Affairs, and Purchasing.  Position will also interact with technical and sales vendor representatives.  

    SUPERVISOR RESPONSIBILITY

  • No personnel will report directly to MFG Quality Specialist.  Position will indirectly oversee, mentor or coach other Manufacturing staff.  Special roles of leadership and dotted-line relationships may arise for new or junior staff.


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

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