Job Listing Description

Quality Specialist

Chipton-Ross is seeking a Quality Specialist for an opening in West Hills, CA.

This position is responsible for monitoring/addressing/tracking quality issues that arise from Non-Conformance (NCR) or from Internal/External quality system audits. This position is also responsible for assisting the QA Supervisor and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities. Additional support of routine QA department standard operating procedures is also expected when necessary.
1. Perform computer operations for data entry, and provide tracing/trending reports.

2. Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory).

3. Initiates RCA process and notifies QC technicians.

4. Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance.

5. Responsible for the assignment of CAPA reports (corrective/preventive action requests) to NCRs.

6. Ensure all nonconforming product(s) are identified and removed from use.

7. Ensure completion and accuracy of all associated quality records related to non-conformance and CAPA reports.

8. Participate in product related team meetings and/or performance reviews, as needed.

9. Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).

Requires a minimum of two (2) years job related experience in a regulated manufacturing environment.

Background in IVD products is preferred. ASQ/RAB affiliation preferred.

Knowledge of:

1. Detailed knowledge of ISO and GMP regulations which govern an IVD product manufacturing.

2. Knowledge of statistical process controls and GMP CAPA requirements.

3. Tracking and trending tools and reporting techniques.

Microsoft Office Skills:

Able to create presentations, work with spreadsheets, prepare reports

and write procedures utilizing MS Word, Excel and PowerPoint software applications

Ability to:

Provide accurate QS tracking and trending reports. Good procedural writing skills a plus. Exercise independent discretion and judgment in execution of duties. Plan and organize oneself in a consistent manner. Be a self-starter with the ability to positively motivate others in a cooperative fashion. Establish and maintain effective working relationships with other staff members. Effectively communicate both orally and in writing to management, customers and regulatory personnel. Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.

Accredited Bachelorís Degree in the Biological Sciences or equivalent work experience.

1st Shift, Monday-Friday 9am to 5pm

Job Number: 188474
Job Location: West Hills, CA
Rate: $25 to $28.00 DOE
Duration: 3 Months
Input Date: 01/01/2021
Attention: Billy James
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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