QC Associate

Location
Novato, California
Posted
Sep 18, 2021
Ref
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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Contract
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. 

Key issues in all work assignments must be identified regardless of complexity. The chosen candidate is expected to follow and be proficient in knowledge and theory behind SOPs, understand the rationale behind requirements, apply consistent critical thinking skills to routine and non-routine work, and facilitate decision-making forums that involve suitable SMEs. He/she should possess the ability to independently recognize, initiate, and investigate any deviations from procedures, and be versed in fully supporting reasoning for conclusions.

Information must be appropriately communicated and escalated to proper audiences. Attendance at team meetings with some facilitation of discussions is essential, providing focus and accounting for the impact of department initiatives to the greater organization. The chosen candidate will be proactive and invested in his/her role and engage with colleagues to foster mutual respect and ensure the collective team environment carries an overall positive and productive atmosphere.


    1. Ensure quality systems are in place and followed (investigation of deviations, LIRs, alert/action excursions, adverse trend and facility child investigations).

    1. Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.

    1. Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.

    1. Manage lab systems (MODA / LIMS) such as builds and upgrades for continued functionality. Efforts include the resolution of MODA / LIMS discrepancies and approval of MODA / LIMS entries.

    1. Facilitate laboratory equipment maintenance such as PM, calibration and equipment status. Coordinate CMMS processes such as work orders and calibration due dates.

    1. Coordinate troubleshooting efforts of instrumentation or reagents through hypothesis testing, laboratory notebook studies and communication with vendor technical support.

    1. Identify proper CAPA as the result of adverse trends or discrepancies plus, if applicable, sequential Effectiveness Check strategy, and provide ownership whenever necessary.

    1. Manage and facilitate lab documents revisions to ensure on-time completion. Support implementation of system improvements and procedural revisions, with emphasis on increasing laboratory efficiencies and safety.

    1. Manage contract lab tests and review of data from these labs.

    1. Create blanket purchase orders based on the needs of the QC labs.

    1. Act as training coordinator for QC analysts to maintain compliance.

    1. Perform gap assessments of methods and processes in accordance with updates to quality and method regulations or guidance documents.

    1. Support implementation of optimization and continuous improvement projects.

    1. Extend subject matter expertise into the development of investigational, comparability study, validation or method transfer protocols.

    1. Provide support to validation or special laboratory studies with data compilation, verification and analysis.

    1. Assist in the composition of technical and/or validation reports.

  1. Perform other responsibilities as deemed necessary.

 
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.