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Analyst, QC I (TEMPORARY)

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. 

Duties


Note: This position is scheduled for either day shift (8:00 – 17:00) or swing shift (1400 - 2300) and will require at least one weekend day (Saturday or Sunday).



Job Duties:


The Quality Control Analyst’s main job responsibility is to manage the Quality Control In-Process department documents to ensure their accuracy, quality and integrity. The candidate will organize, maintain, track and archive department documents and records while adhering to the BioMarin's document lifecycle procedures and in accordance with the records retention schedule. The QC Analyst may be required to develop new processes and improve upon the current system to allow retrieval of data records more effectively. Periodically, the QC analyst may be responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery. The candidate may also assist with audits of data record systems and perform administrative tasks as needed.



Additional daily duties will include sample receipt and accessioning, laboratory housekeeping and infrastructure maintenance responsibilities, reagent preparation and lab supply management. As well as general support of routine testing analytical method or equipment validation, assay method/procedure development, and/or conducting investigations.



If time permits the Quality Control Analyst may be trained to perform select microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities. All microbiological and analytical tests are performed under cGMP guidelines.



Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors.


Skills


Qualities:


We are seeking a candidate who is self-directed, has the ability to work independently and is highly-motivated. The QC analyst will often work in a fast-paced and deadline driven environment, so it's important they can stay focused and carry out their tasks in a timely and accurate manner. They should be detail-oriented, dependable and trustworthy since they come in contact with complex and sensitive documents.



Skills:


The QC analyst should have the ability to prioritize, manage time well, multitask and troubleshoot. Strong interpersonal, communication and customer service skills are also essential because the QC analyst will regularly communicate with internal and external business partners.



Must have excellent record keeping, written and verbal skills.



Ability to perform most tasks without supervision.



Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices is a plus.



Able to lift up to 25lbs



Computer literacy is required, proficiency with Microsoft Word and Excel is essential.



Must have excellent record keeping, written and verbal skills.



Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Education


Bachelor of Science in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


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
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