QC Microbiologist (33098)
Job Details
Full Job Description
Job Description:
Under minimal
supervision, successful candidate would be responsible for one or more
of the following activities in QC including microbiological testing,
method transfers, sample and data management and equipment
maintenance. This role is for an experienced and technically strong
associate who will spend 90% of their work day performing testing. The
successful candidate would contribute to team by ensuring the quality
of the tasks/services provided by self and contribute to the
completion of milestones associated with specific projects or
activities within team. This role will support manufacturing
operations, as such some extended hours, shift and weekend work may
Job duties are as
follows but not limited to:
• Endotoxin
testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug
product samples
• Sterility testing
• Water sampling
• Lab Support
duties such as Biological Indicator testing, Growth Promotion, Media
Preparation, Identifications and Autoclave.
•
Writing technical reports
•
Perform analytical testing as a main priority with efficiency and
accuracy
• With a high degree of technical
flexibility, work across diverse areas within the lab
•
Plan and perform multiple routine/ non-routine methods and procedures
with a large variety of assays.
• Report,
evaluate, archive, trend and approve analytical data.
•
Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled
documents.
• Participate in audits,
initiatives, and projects that may be departmental or organizational
in scope.
• Write protocols and perform assay
validation.
• Introduce new techniques to the
lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and
operational excellence improvement on a continuous basis.
• Review and Approve lab results
•
May participate in lab investigations.
• May
provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organization on
various teams
• May interact with outside
resources
Basic Qualifications:
• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing
and testing of pharmaceutical products
QC Microbiologist (33098)
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