BioPhase 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 early-stage, Orange County Biotechnical company.
Salary Range : $25 - $35/Hour
Purpose of Position
Seeking a highly motivated and enthusiastic individual to join our dynamic biotech industry team.
The QC Specialist will perform inspection and testing of incoming materials, in-process samples, and finished products to ensure the materials and products conform to specifications/requirements or support product research/development.
They will be responsible for hands-on laboratory testing and reporting of test results. Track and schedule calibrations/preventive maintenance of equipment, instruments, and tools. Archive QC documentation.
Responsibilities:
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.
Required Knowledge:
Bachelor's degree or higher is required in science or engineering.
A minimum of 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.
Skills and traits:
Someone who gets things done without perfect resources, is innovative, and works with a sense of urgency.
Results oriented - drives progress & excellence.
Ability to work independently with minimal supervision.
Ability to work in a fast-paced environment and to balance and prioritize workload to support production schedule.
Effective interpersonal and communication skills.
Tech-savvy and able to learn new software quickly.
Well organized and attentive to detail.
Contributes to a collaborative and inclusive work environment.
Someone who has high standards, takes ownership, and is invested in the outcome.
Experience working in in-vitro diagnostic device companies and/or start-ups and small companies.
Flexible and willing to take on various responsibilities.
Please send resumes to vanessa@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!