QC Specialist

4 months ago


Orange County, United States BioPhase Solutions Full time
Job DescriptionJob DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QC Specialist to work for an Orange County area medical device company.Pay Rate: $25-35/hourResponsibilities:
  • Perform visual, dimensional, and functional inspections and/or testing across all components, subassemblies and finished medical device products using all applicable tools and equipment to ensure conformance with design specifications.
  • Perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
  • Ensuring all necessary samples are pulled and tested per procedures.
  • Determine acceptability and/or identify defective raw materials and finished products following established procedures and specifications.
  • Provide feedback on all quality related issues/results.
  • Track equipment status using a spreadsheet, including making equipment labels, and scheduling/completion of equipment calibration/preventative maintenance.
  • Perform testing, analysis and data reporting of test samples, utilizing basic analytical instrumentation/techniques such as pH, conductivity, etc.
  • Draft procedures, work instructions, and reports in support of quality systems, manufacturing, and research/development.
  • Initiate and/or draft non-conformance and out of specification reports.
  • Support customer complaint investigations, as required.
  • Perform all activities in compliance with cGMP requirements.
  • Maintain and archive documentation in regulatory compliance for instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other product or project specific documentation.
  • Additional projects and/or duties as assigned.
Qualifications:
  • Bachelor’s degree or higher is required in science or engineering.
  • 5+ years of inspection and testing experience in GMP environment in medical device or pharmaceutical industries is required.
  • Experience with proper usage of various metrology/inspection tools and equipment, hand eye coordination, and high manual dexterity.
  • Experience with various inspection procedures, including the ability to contribute to and support the development of procedures.
  • Strong communication skills and interpersonal relationship skills.
  • Excellent written communication skills
  • Ability to compose and document processes in a concise and easy for the end user to understand.
  • Proficient computer skills specifically with Microsoft Excel and Word.
  • Experience working in a regulated environment under ISO 9001, ISO 13485, or other GMP related industry.
Please send resumes to vanessa@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities

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