Category: Science & Technology

Employment Type: Contract

Reference: BH-370844

Quality Ops Analyst needed for a contract opportunity with Yoh Scientific's client located in San Diego, CA.

This position will be for a major biotech company, and is suitable for someone with bachelor's degree or quality/ compliance experience in IVD, medical device, or biotechnology organization.

Shift: Mon to Fri, 7 am to 4:30 pm/ 8 am to 5 pm (flexible)

Key Responsibilities

• Responsible for day-to-day administration of company's Quality Assurance programs in support of the company's Quality Management Systems.
• Involved in the development, implementation and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820 QSR), ISO 13485), and other applicable quality and regulatory standards.
• Coordinates and participates in internal audit activities and key quality initiatives as appropriate.
• Recommends CAPAs and SCARs based on top issues seen from NC activities and supports the compilation of device master records, device history records, training records, CAPA records and other Quality System records
• Administer and maintain training records and other Quality System records for the Quality System department.
• Support review and maintenance of manufacturing Device History Record (DHR).
• Perform instrument release activities.
• Drives timely resolution of deviations related to DHRs, disposition of and escalates in case of delays.
• Support manufacturing in rework. Ensure rework activities are adequately documented and risk impact outlined.
• Assist in training in GDP and other relevant Quality System training.
• Support the equipment calibration system by conducting periodic audits to ensure equipment used in manufacturing is within the allowable calibration date, generating reports as required of upcoming calibration due and assisting in the overall calibration equipment program.
• Support and preventive maintenance program
• Support Quality system audit activities
• Prepare and quality reports, data, and key performance indicators for management reviews.
• Ensure proper handling, quarantine and disposition of discrepant material
• Identify top issues and recommend CAPAs/SCARs and drive to closure where required.
• Conduct failure investigations associated with complaints as required.

• Bachelor's Degree
• Quality or Compliance related experience in IVD, Medical Device, or Biotechnology organization

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs