Analyst, QC I
Company: Randstad
Location: Novato
Posted on: August 3, 2022
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Job Description:
Job Title: Analyst, QC IDuration: 10 MonthsLocation: Novato, CA,
94949Summary:The 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.
Skills:Functional 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.Responsibilities:
Keywords: Randstad, Novato , Analyst, QC I, Professions , Novato, California
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