QC Microbiology Associate
Company: BioMarin Pharmaceutical
Posted on: May 27, 2023
Who We Are
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
- Define validation program requirements and develop/implement
strategies for validation programs to ensure all validations are
performed and adhere to current compendial requirements.
- Develop experimental design for validation protocol execution
and supplemental studies as appropriate. Coordinate and plan method
validation activities, investigations and technical studies.
- Ensure quality systems are in place and followed, and execute
principal investigation of deviations, LIRs, excursions, adverse
trend, and child or assessment records as needed.
- Evaluate routine assay validity, calculate and summarize
results, analyze data per expectations or specifications. Assist
with compilation and verification of trend reports.
- 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.
- Coordinate troubleshooting efforts of instrumentation or
reagents through hypothesis testing, laboratory notebook studies
and communication with vendor technical support.
- Support tracking of contract lab tests and review of data from
- Plan and coordinate the development and publishing of
investigational, comparability study, validation or method transfer
- Initiate and lead validation or special laboratory studies and
track data compilation, review, verification and analysis to
- Manage the creation, review and approval of technical and/or
- Apply proactive communication upon occurrence of issues or
genesis of improvement concepts. Represent department needs as part
of cross-functional teams while fostering collaboration in the
deciphering of paths forward and action plans.
- Readily mentor and develop staff within the method design space
and/or technical aspects of QC objectives and build a scientific
focused foundation for the team.
- Perform other responsibilities as deemed necessary. Skills
- Continuously looking internally and externally for best
practices and areas for improvement.
- Provides clear instruction and direction to team members to
assure fast action and effective completion of technical,
laboratory and/or compliance related projects.
- Leads by example with thorough, effective laboratory work and
decision making that helps to motivate and inspire the team to
broaden their knowledge base and elevate performance.
- Understands patient and customer needs and builds relationships
as required to meet department objectives. EXPERIENCE
- Detailed knowledge of quality management systems, current Good
Manufacturing Practices, longstanding expertise and practice with
- Ability to deliver all ideas and work with a compliance mindset
and alignment with pharmacopeia regulations and international
- Demonstrated working knowledge and critical thinking with
respect to certified functional activities, with subject matter
expertise on several technical modules or quality management
- Excellent documentation, written and verbal communication
skills are essential.
- Must possess the ability to perform routine and non-routine
tasks under minimal supervision while modeling initiative,
self-direction, objectivity and team advocacy.
- Ability and willingness to provide input to the entire group,
with proficiency in both facilitating active and open discussion
and laying groundwork for logical decision making.
- Working knowledge of cGMP regulations pertaining to test result
disposition, stability protocol generation and execution and
critical reagent program management, is desired.
- Computer literacy is required, proficiency with Microsoft Word
and Excel is essential, experience with Microsoft PowerPoint,
Access, Project and/or Visio is desired.
- Expertise with laboratory software functions, such as within
MODA or LIMS, is optimal.
- Fluency with experimental design and data trend / comparability
evaluation per statistical models, with some advanced software
experience such as with JMP or Power Pivot.
- Must have a quality service attitude and focus, exhibit
flexibility and willingness to work additional hours to meet
production or laboratory process requirements. Education B.S.
degree, or equivalent, in a biological or biochemical science and
-at least 5 years of experience in a pharmaceutical laboratory,
with at least 2 years as part of a QC organization PREFERRED
QUALIFICATIONS Candidate must be a motivated employee capable of
working in a fast-paced environment to produce quality and timely
results. Strong time management and organizational skills.
Experience managing projects and processes. Strong people skills.
Experience with meeting organization and facilitation. Practiced in
technical training element and program deployment. Ability to
foster a team-oriented environment. Experience authoring and
reviewing SOPs, test records, work instructions, OJTs, and other
controlled documents. In the U.S, the -temporary worker pay for
this position is *31* to *50* per hour. The base pay actually
offered will take into account internal equity, and may also vary
depending on candidate's geographic region, job-related knowledge,
skills, and experience amongst other factors. 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, Novato , QC Microbiology Associate, Other , Novato, California
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