Analyst, QC I
Posted on: August 3, 2022
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:
- 1.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
- 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
- 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
- 11.Provide input or assay support to the progression of test
method validation, investigations, technical studies, and method
- 12.Attend team huddles and department meetings, generate ideas
for laboratory infrastructure improvements and method
- 13.Perform other responsibilities as deemed necessary.
Qualifications:1.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.
Keywords: Randstad, Novato , Analyst, QC I, Professions , Novato, California
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