Quality Assurance Specialist jobs in Elk Grove, CA

RESPONSIBILITIES:

2nd shift: 2pm -10pm Mon-Fri

• The Quality Technician is responsible for performing label verification, finished goods inspection, line clearance and quality review on the production floor. They support the day-to-day activities of the Quality department while adhering to ISO 13485, EU IVDR, and FDA QSR regulatory requirements, standards, procedures, and policies.
• General understanding of Quality Assurance/Quality Control in a manufactured, regulated environment
• General knowledge of FDA QSRs cGMP and ISO 13485 or other related industry standards
• Knowledge and experience in IHC, ELISA and Bioburden preferred
• Knowledge of SAP and/or SAP NEXT preferred
• Basic knowledge of CAPAs, deviations, and change controls preferred
• Effective oral and written communication skills
• Able to read, analyze, and interpret instructions, correspondence, policies, procedures, technical journals, report and data
• Good computer skills, including Microsoft Office
• Good organizational skills and attention to detailRequires some formal training and practical experience in addition to training on the job.

QUALIFICATIONS:

• High school diploma or GED
• MUST HAVE - basic Laboratory and Quality experience
• Exp with: label verification, finished goods inspection, line clearance and quality review.
• Some exp in Quality Assurance/Quality Control in a manufactured, regulated environment
• Basic knowledge of CAPAs, deviations, and change controls preferred
• Good computer skills, including Microsoft Office
• General knowledge of Biotech/ Pharmaceutical, FDA QSRs cGMP and ISO 13485 or other related industry standards preferred

Job Type: Contract

Pay: $25.00 - $27.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• High school or equivalent (Required)

Experience:

• Manufacturing: 1 year (Required)
• Laboratory: 1 year (Required)
• Quality review: 1 year (Required)
• CAPA DEVIATION: 1 year (Preferred)
• Biotech/pharma: 1 year (Required)

Work Location: On the road