Summary

To support QC functions within our Drugs of Abuse test manufacturing facility. The position will primarily focus on incoming, in-process and final QC testing, labeling, document inspection results and enter raw material inventory data to ensure the quality and functionality of manufactured products.

Tasks and responsibilities:

· Perform and document incoming, in-process, and final QC testing of in-vitro diagnostics devices to meet compliancy requirements including ISO, FDA and international regulations.

· Document QC test results on QC Testing Form, retain retention samples as needed.

· Familiarity with all aspects of product and be able to identify defects.

· Use Agile to issue Quality Incident (QI) reports; perform root cause investigation and write investigation report.

· Ensure timely release of product.

· Ensure cleanliness of the QC lab.

· May be required to work overtime (may include weekends) as defined by the needs of the department.

· Work effectively and independently. Cooperatively work with others in all matter of the organization.

· Able to prioritize and handle multiple tasks and responsibilities, attention to detail, Performs well under stress.

· Good English written and verbal communication skills. Basic computer proficiency.

· Moderate computer skill and moderate knowledge of MS Excel and MS Word.

· Assist the head of QC department with any necessary tasks and other duties as assigned.

· Carries out duties in compliance with established business policies.

· Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.

· Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

· Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

· Perform other duties & projects as assigned.

Preferred educational background:

BA/BS degree in chemistry or biology or equivalent experience preferred.

Preferred experiential background:

0-2 years’ experience with FDA Class I/II device or other regulated industry preferred.

Proficient in spoken and written English
Excellent interpersonal skills.

Excellent computer skills including Microsoft Excel, Word, Agile and other ERP systems

Job Type: Contract

Salary: $20.00 - $24.00 per hour

Experience level:

• 2 years

Schedule:

• 8 hour shift

Work setting:

• In-person

Education:

• High school or equivalent (Preferred)

Experience:

• final QC testing, labeling: 2 years (Preferred)
• regulated industry: 1 year (Preferred)
• testing of in-vitro diagnostics devices: 1 year (Preferred)

Ability to Relocate:

• Pomona, CA 91767: Relocate before starting work (Required)

Work Location: In person