Document Control Associate (IVD Medical Device, Immunoassay)

Biomerica Irvine, CA USA

At Biomerica, we improve lives by developing, manufacturing and marketing products designed to enhance the health and well-being of people, while reducing healthcare costs. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop diagnostic and therapeutic diagnostic solutions for our customers. We are fast-growing NASDAQ traded global company that drives innovation in diagnostic in Gastrointestinal and Inflammatory Diseases. Being part of our team is much more than a job, it is opportunity to an impact in people lives.

Description

To provide support to the Quality Assurance departments. The most critical function is the maintenance, updating, routing, monitoring and implementation of Quality System documents within the various document control system at Biomerica, Inc. Maintaining specifications and monitoring Quality System document changes in the change control system is included in this function.

Essential Duties and Responsibilities

• Maintain and improve Document Control System. Manage the issuance process and monitor all the quality system documents in the approval and training processes. Ensure Quality System documents are initiated, updated, reviewed, and approved per internal procedures/specifications and external requirements (FDA, ISO 13485:2016, IVDD, and IVDR). Maintain associated tracking files.
• Evaluate document changes to determine the level of training required.
• Collaborate with employees to ensure company training goals are met per approved Biomerica Employee Training Matrix.
• Support Quality Status Update Meeting to monitor and track the status of Corrective Actions and Preventive Actions (CAPAs), Customer Complaints and Customer Inquiries (CC/CIs), Deviations (DRs), Nonconformances (NCMRs), Reworks, Process Change Requests (PCRs), and Quality Plans (QPs) to ensure that necessary action items are completed in a timely manner with adequate effectiveness.
• Assist in internal and external audits and provide support for regulatory inspections.
• Scan paper records to create electronic records (DHRs, RIRs, etc.)
• Perform other duties and assignments as required.

Qualifications and Requirements

• BS/BA degree in science discipline (Biology, Biochemistry, Microbiology, Chemistry and etc.).
• Zero-three years Document Control experience in the medical device and/or IVD medical device and/or pharmaceutical industry.
• Experience with electronic document management tools (EDMS, Master Control, etc.) and ERP/MRP software desired.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint) and the ability to learn new software programs.
• Excellent organizational skills, detail oriented and ability to multi-task.
• Excellent communications skills, both written and oral.

Job Type: Full-time

Pay: $22.00 - $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Document management systems: 1 year (Required)
• Microsoft Office: 2 years (Required)

Work Location: In person