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.
The QC Associate reports to a Quality Control Product Supervisor and/or manager and is responsible for the following:
- Providing leadership, vision and daily test guidance to the Bio-Chemistry or Separations team
- Performing testing and reports results to ensure a high level of quality and compliance
- Resolving problems requiring in depth technical knowledge
- Mentoring and providing guidance to junior staff
The position requires developed technical expertise, a strong understanding of quality compliance and GxPs, and good leadership skills. They will be expected to work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, performing routine testing, reviewing routine testing results, maintaining the laboratory in an audit ready state, performing investigations, and communicating laboratory issues to management and junior staff.
The QC Product Associate II must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. The position requires some combination of working experience and knowledge within some of the following methodologies:
Liquid Chromatography, Ion Chromatography, SDS-PAGE, Capillary Electrophoresis, Cell based biotechnology assays, Gas Chromatography, Spectroscopy, Solid oral dosage testing, Basic chemistry skills.
The QC Product Analyst IV must develop skills in the operation and routine maintenance of various analytical instruments and computers. They must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills to work with their supervisor/manager in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation.
- Review logbooks and quality records for completeness, accuracy, and consistency to meet the compliance requirement and/or specification.
- Participate in team meetings including preparation and presentation of meeting materials.
- Develop new approaches to solve problems identified during quality assurance activities.
- Assist in the continuous growth of the Quality Department.
- Lead, mentor, and coach junior level analysts by promoting a culture of quality and GxP awareness.
- Perform quality testing and other duties as assigned.
- Adhere to department goals and help drive department performance.
- Ensure operation personnel comply with government and industry quality assurance codes and standards.
- Maintains the laboratory in an inspection-ready state. Ensures other routine laboratory functions/chores/safety for the QC laboratory are met to meet business needs.
- Participate in audits, inspections, to ensure compliance with policies and procedures, and implements corrective actions as required.
- Familiar with regulations GxP, 21CFR, USP, EP, and ICH regulatory requirements.
- Holds self and others responsible to abide by department and company policies, procedures, and best practices.
- B.S./B.A. in Science (major in biology-biochemistry-chemistry) with 4+ years of relevant laboratory experience
- A.S. with at least 7 years of relevant laboratory experience
- 4+ years in a cGMP/GLP laboratory; quality control experience is preferred.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Demonstrate strong leadership skills through past work history.
- Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel, LabWare LIMS, CMMS, and TrackWise.
- Strong written, documentation, verbal, and communication skills.
- Works independently as well in a team environment.
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.