QC Specialist

Job Description

Job Description

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 Orange County area medical device company.

Pay Rate : $25-35 / hour

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.
• 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 [email protected] and visit our website at www.biophaseinc.com for additional job opportunities!!!