1+ months

Quality Assurance (QA) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108
**Quality Assurance (QA) Inspector, San Diego, CA**

**Essential Duties and Responsibilities:**

+ Proficiency in understanding and interpreting FDA and ISO 13485 rules and regulations and their application at all levels throughout the organization, including the manner in which quality programs (i.e. CAPA, NCMR, storage, labeling, equipment calibration, training, etc.) are established, maintained and documented to ensure compliance with these rules and regulations.

+ Completes and maintains timely training on the departmental, safety, technical, record-keeping and Quality Systems Regulations (QSR) aspects of the position.

+ Assists in writing, updating and maintaining Standard Operating Procedures (SOPs) and policies associated with the Q.A. Incoming Inspection group according to the Electronic Change Management (ECM) system. When necessary, informs area managements of necessary changes to current methods and systems to ensure continuous improvement of the Q.A. Incoming Inspection process.

+ Helps establish and maintain effective work relations and communication within the Q.A. Incoming Inspection group. Helps identify issues, concerns, etc. within the Incoming Inspection group that may have an overall effect on the efficiency, cohesiveness and teamwork within the Q.A. Incoming Inspection Group.

+ Completes and maintains accurate quality documentation and/or any associated documentation for all quality activities according to QSRs by Incoming Inspection personnel.

+ Assists with the interactions with the FDA and ISO notified bodies including inspections and/or audits, as necessary.

+ Assists with the correction and/or prevention of deficiencies.

+ Assists Q.A. Manager with ERP inventory transactions in an accurate and timely manner.

+ Assists in the investigation, analysis and implementation of corrective actions for compliance problems in conjunction with a manager/supervisor and/or the assistance of others.

+ Ensures supplies of materials, reagents and equipment required to meet quality activity schedules (i.e. monthly Deionized Water System monitoring, monthly air and surface monitoring, etc.) are available. Alerts the manager of any material shortages, potential expiration dating problems, equipment requirements and/or other circumstances, which may cause delays in meeting assigned monitoring timeframes.

+ Completes work in compliance with established safety, ergonomic and environmental programs as required by OSHA regulations and corporate safety personnel. Reports all safety hazards immediately and initiates actions to protect personnel from injury until a hazard is remedied. Ensures work areas and equipment are kept in a clean and functional state in order to comply with QSR guidelines. Immediately reports all malfunctions, out-of-tolerance conditions or calibration expirations to manager/supervisor.

**Job Requirements:**

+ High School diploma required.

+ Working knowledge of FDA regulations and ISO 13485 standards required.

+ Knowledge of Quality Systems Regulations as they apply to in vitro diagnostics manufacturing preferred.

+ Experience performing QA incoming inspections in a GMP environment

+ Some experience assisting with FDA and ISO inspections / audits

+ Some experience assisting with the correction and/or prevention of deficiencies

+ Experience assisting with SOP writing and ERP inventory tracking is also helpful.

**For Immediate Consideration, Apply Today! Questions?** **Call Grace at 714-971-0721 or Email at**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-07-19 Expires: 2019-09-19

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Quality Assurance (QA) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108

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