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Mortgage Jobs in Fremont, CA

Sr. QC Associate

Mindlance
  • Fremont, CA
  • $35.22–$37.50 Per Hour
  • Instant Apply
15 days ago

Job Description

  • The SR QC Associate is assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing.
  • This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).
  • The SR QC Associate coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs).
  • This role performs duties under limited supervision and according to standard operating and QC procedures.
  • Trains other associates and technicians on methods and processes.
  • Executes independently, with adequate training, three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff.
  • Manages and reviews fundamental tasks such as but not limited to buffer prep, TCU maintenance, and cleaning.
  • Identifies and implements fundamental improvements to lab processes compliance activities.
  • Responsible for routine quality and compliance activities (authoring of test methods, forms, SOPs).
  • Documents work according to cGMP and cGDP.
  • Adheres to established regulations and follows cGMP established by site.
  • Reports abnormalities and deviations in a timely and accurate manner.
  • Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
  • Maintains and improves lab areas according to predefined standards (5s).
  • Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
  • Conduct group training on compliance topics and scientific principles as needed.
  • Performs testing and review within several different analytical technologies.
  • Reviews and trends analytical data and compliance processes to identify out of trends.
  • Authors routine compliance documents.
  • Identifies process anomalies and areas for improvement for operations.
  • Provides compliant and smart solutions for moderately complex methods and testing issues.
  • Coordinates work within the team and cross functionally.
  • Reviews data and identifies discrepancies and ensures they are properly investigated, assessed and appropriate root causes are put in place.
  • Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.
  • Trains other associates and technicians on methods and compliance.

Skills:
  • Previous QC Experience preferred.
  • Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.
  • Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
  • Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
  • Proven experience with technical review, analysis, and interpretation of scientific data.
  • Strong written and verbal communication skills.
  • Experience with computer-based systems and ideally experience with process control systems
  • Previous experience reading and understanding SOPs and/or methods and document work in a written format applying cGMP/GDP standards.
  • Ability to work as part of a high performing team and collaborate effectively with staff.
  • Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed.
  • Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
  • Strong focus on execution of non-routine analytical methods or processes.
  • Strong technical knowledge in analytical methods.
  • Ability to work independently with very little supervision.
  • Champions problem resolution.
  • Knows when to escalate to line management.
  • Strong technical knowledge in analytical methods.
  • Work independently with very little supervision, champions problem resolution, knows when to escalate to line management, and provides compliant and smart solutions for moderately complex method and testing issues.

Education:
  • High School Diploma with six (6) years of experience in cGMP regulated industry or equivalent.
  • OR, Associate Degree with four (4) years of experience in cGMP regulated industry or equivalent.
  • OR, Bachelor's Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.


EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

Numbers & Facts

LocationFremont, CA
Salary$35.22–$37.50 Per Hour

Skills

  • Analysis Skillsunmatched
  • Analytical Chemistryunmatched
  • Assaysunmatched
  • Biological Assayunmatched
  • Cleanroomunmatched
  • Communication Skillsunmatched
  • Computer Skillsunmatched
  • Control Systemsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Detail Orientedunmatched
  • Drug Productsunmatched
  • Environmental Microbiologyunmatched
  • Environmental Monitoringunmatched
  • High Performance Liquid Chromatography (HPLC)unmatched
  • High School Diplomaunmatched
  • Housekeeping/Cleaningunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Materials Testingunmatched
  • Operational Improvementunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Process Control Engineeringunmatched
  • Process Developmentunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Controlunmatched
  • Regulationsunmatched
  • Root Cause Analysisunmatched
  • Safety Standardsunmatched
  • Scientific Principlesunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Team Playerunmatched
  • Test Plan/Scheduleunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Training/Teachingunmatched
  • Trend Analysisunmatched
  • Validation Testingunmatched
  • Writing Skillsunmatched

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