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Analyst, QC Raw Materials

Location Novato, California
Description

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.

Description:

SUMMARY

The Quality Control Raw Materials Analyst, under direct supervision, is responsible for performing biochemical and chemical evaluations of all raw materials.

The position is a Monday through Friday, day shift position.

The incumbent, under direct supervision, will be responsible for analyzing raw materials following established procedures.  Functions include performing a wide array of chemical analyses, including FTIR and spectrophotometric scans, physical analyses, HPLC, GC, method/ equipment validation, and reagent preparation.  Must be able to comfortably lift 50-pound containers.  Attention to detail is a requirement.  Work assignments will encompass activities from routine to complex in nature with the ability to recognize deviations from the accepted practice.   The incumbent will be responsible for completing assignments timely, for troubleshooting, and for follow-up on any testing issues.  Knowledge of cGMP is required.  They should be able to work independently and deal with multiple tasks.  Good record keeping, organizational, written and verbal communication skills are essential.  The incumbent must be willing to work second shift, overtime, weekends and holidays as required. 

Effective performance ensures that the Quality Control department operates effectively and efficiently, and the company achieves the annual objectives with respect to the established goals and budget.  Performs all activities in a compliant manner.

RESPONSIBILITIES

  • Perform, under direct supervision, chemical and biochemical analyses of incoming raw materials under cGMP to meet specified timelines.
  • Evaluate results and trend data.
  • Maintain raw materials log and control of laboratory inventories.
  • Coordinate and track outside laboratory testing activities.
  • Participate in the preparation of investigations, summaries and reports.
  • Participate in method validation, develop/write procedures and troubleshoot assays.
  • Maintain the laboratory in an inspection ready state.
  • Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.
  • On rare occasion, provide on call coverage for Out of Specification conditions to support production testing and quality control laboratory equipment.

EXPERIENCE

Required Skills:

B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at 0 - 1 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.

  • Must have a positive, team minded personality

  • At least one year in a cGMP laboratory and quality control experience beneficial, but not required.

  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred

  • Demonstrated working knowledge related to specific functional activities.

  • Ability to perform most tasks with moderate supervision.

  • Computer literacy is required.

  • Experience with Microsoft Word and Excel required; experience with Labware LIMS, O365 a plus.

  • Must have excellent record keeping, written and verbal skills.

  • Work in a GMP laboratory and be compliant with the laboratory procedures.

  • May work with biohazardous materials, hazardous chemicals, and radioactive materials.

  • Comfortable lifting 50 pounds.

  • Ability to work independently and to deal with multiple tasks.

  • May be required to work second shift, overtime, weekends and holidays.

  • Moderate supervision and minimal guidance should only be necessary for specific ad hoc assignments.

  • Organizational skills as well as good written and verbal communication skills essential.

  • Must work effectively as a member of the BioMarin team.

  • Must have a Quality service attitude and be willing to work additional hours to meet deadlines and requirements.

    Desired Skills:

  • Experience in a cGMP laboratory; quality control experience beneficial.

  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred

  • Familiarity/experience with Compendial testing (USP, EP, JP) preferred

  • Familiarity/experience with complex instrumentation (HPLC, GC) preferred

  • Familiarity/experience with Labware LIMS preferred

    EDUCATION

    B.S./B.A. in Science (major in biology-biochemistry-chemistry or related field) with at 0 - 1 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.

    EQUIPMENT

    Experienced with physical and chemical methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. 

    CONTACTS

    Reports to Quality Control Supervisor. 

    Interacts with personnel in the department and among several departments, including but not limited to Manufacturing, Quality, Maintenance, Engineering, and Process Development.

    SUPERVISOR RESPONSIBILITY

    Not Applicable

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.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance