QC Analyst
Company: BioMarin Pharmaceutical Inc.
Location: Novato
Posted on: August 5, 2022
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Job 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. - - -DutiesThe Quality Control Process
Monitoring (QCPM) Analyst is responsible for performing
environmental monitoring and microbiological/analytical test
methods on in-process intermediates and varying stages of drug
products under minimal supervision and within cGMP guidelines, to
support further manufacturing of commercial and clinical
therapeutics. This role will involve knowledge that includes but is
not limited to the following analyses and concepts: Environmental
monitoring, Water testing, Protein determination by BCA, Bradford,
and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden
quantification, HPLC, Total Organic Carbon, microbial
identification and challenge studies, aseptic techniques, and
method validation. -The hours of this position will either be 4 x
10hr shift. Must be willing to work at least one weekend day.
Candidates should be open to all potential day or swing shift
options.SkillsCHARACTERISTICSFunctional activities may include:
performing a wide variety of microbiological and/or analytical
assays, perform environmental monitoring sampling and testing of
facilities, equipment, and utilities, maintaining test sample
throughput, monitoring lab supplies, preparing reagents,
contributing to process and method validation studies, supporting
investigations and equipment validation, and brainstorm further
development or improvement ideas for procedures. 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,
and be capable of accepting and incorporating feedback. Must also
demonstrate the ability to both manage time and prioritize routine
work effectively.Employee must be able to interpret results against
defined criteria, begin to apply critical thinking to routine work.
He/she should demonstrate an ability to evaluate results against
trend reports, serve some degree of troubleshooting and capacity as
trainer, and embrace an active role in following up on atypical
results or issues.Communication of relevant information must be
made to appropriate audiences, and attendance of necessary team
meetings with some participation in discussions is essential.
Employee should also be actively engaged in his/her role, exhibit
frequent volunteerism as the work schedule flow permits, and
maintain a positive attitude. He/she must be willing to work second
shift, overtime, weekends, and holidays as
required.RESPONSIBILITIES1.Timely facilitation of incoming sample
receipt and accessioning flow, decipher batch assignments across
all assay types in accordance with agreed upon best
practices.2.Execute microbiological and/or analytical methods to
facilitate in-process testing under applicable cGMP guidelines, as
well as contribute to the prompt reporting of results to meet the
required timetables of internal customers.3.Perform environmental
monitoring sampling and testing of facilities, equipment, and
utilities.4.Evaluate completed assay validity, calculate and
summarize results, analyze data per expected or specification
ranges. Assist with the compilation and verification of trend
analysis reports.5.Perform and collaborate with co-workers to
appropriately share general housekeeping activity assignments, and
ensure systems for laboratory maintenance are adequate for creating
a consistent state of inspection readiness.6.Assist with monitoring
and the control of laboratory supply and critical reagent
inventories.7.Perform growth promotion of media and microbial
identification testing.8.Qualify as trainer for specified methods,
provide training to less experienced staff.9.Provide on call
coverage to support oversight of QC laboratory equipment
functionality.10.Exhibit proactive communication upon occurrence of
compliance risks and deviations from laboratory procedures, perform
initiation of investigation records within required
timeframes.11.Provide input or assay support to the progression of
test method validation, investigations, technical studies, and
method transfer protocols.12.Attend team huddles and department
meetings, generate ideas for laboratory infrastructure improvements
and method optimization.13.Perform other responsibilities as deemed
necessary.EducationQUALIFICATIONS1.Bachelor of Science degree.2.
0-3 years of relevant laboratory experience; QC specific experience
is preferred.3.Experience with quality management systems, current
Good Manufacturing Practices, and QC principles.4.Demonstrated
working knowledge with respect to certified functional
activities.5.Good documentation, written and verbal communication
skills are essential.6.Must possess the ability to perform most
tasks with minimal supervision.7.Computer literacy is required,
proficiency with Microsoft Word and Excel is essential, experience
with Microsoft PowerPoint, Access, or Visio is desired.8.Must have
a quality service attitude and focus, exhibit flexibility and
willingness to work additional hours to meet production or
laboratory process requirements. - PLEASE NOTE: Absent a Medical or
Religious reason that prohibits vaccinations, all our incoming
employees must be vaccinated for COVID-19. 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.
Keywords: BioMarin Pharmaceutical Inc., Novato , QC Analyst, Professions , Novato, California
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