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.

Please send resumes to vanessa@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!

Last updated : 2024-04-26