Quality Control Specialist

  • location: Novato, CA
  • type: Contract
  • salary: $17.23 - $20.27 per hour
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job description

Quality Control Specialist

job summary:
QC Lab Technician

Job Summary

The QC In-Process (QCIP) Technician is responsible for supporting microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under supervision and within Current Good Manufacturing Practices (cGMP) guidelines, to support further manufacturing of commercial and clinical therapeutics.

Functional activities may include but not limited to: maintaining test sample throughput, monitoring lab supplies, preparing reagents, and maintaining general housekeeping.

Work assignments will vary by degree of complexity. Employee is expected to follow Standard Operating Procedures (SOPs), follow instructions in daily activities, 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.

Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential. Employee must demonstrate good documentation skills. Employee should also be actively engaged, motivated, and organized in his/her role. Incumbent must exhibit frequent volunteerism as the work schedule flow permits and maintain a positive attitude.

Job Responsibilities

  • Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance SOPs.
  • Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments.
  • Ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
  • Provides support for routine laboratory functions/chores such as, but not limited to:
  • Assist in test record generation, management, and archiving.
  • Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  • Washing and stocking of laboratory glassware.
  • Monitoring of temperature charts.
  • Cleaning of water baths, refrigerators, and freezers.
  • Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures.
  • Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements.
  • May interact with other departments including, but not limited to, Manufacturing, Validation, Product Development, and Analytical Chemistry.
  • Perform other responsibilities as deemed necessary.
Education & Qualifications

  • Associate in Science degree or high school diploma with 2 years general work experience
  • 0-2 years of relevant laboratory experience; QC specific experience is preferred.
  • Familiar with quality management systems, current Good Manufacturing Practices, and QC principles.
  • Demonstrated working knowledge with respect to trained functional activities.
  • Good documentation, written and verbal communication skills are essential.
  • Must possess the ability to perform most tasks under supervision.
  • Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
  • Must have a quality service attitude and focus.
  • Exhibit flexibility and willingness to work additional hours, and weekends when needed, to meet production or laboratory process requirements.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
location: Novato, California
job type: Contract
salary: $17.23 - 20.27 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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