25 days old

Quality Assurance / Labeling Specialist - Irvine, CA

Kelly Services
Irvine, CA 92604
**Quality Assurance / Labeling Specialist - Irvine, CA**

**Position Purpose:** Execute new global content and packaging/labeling artwork in support of new product launches and base business projects in all divisions of company. Accountable for ensuring that all work associated with updates or changes to global labeling standards / procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through Change Request (ECR) and PDM processes is carried out in compliance with relevant standards and regulations.

**Essential Duties and Responsibilities:**

+ Assess business needs and solve moderately complex problems in an innovative, cost effective and timely manner by collecting detailed requirements and scope in collaboration with BU cross-functional stakeholders Identify risk, and may develop/propose and may lead the execution of new alternatives to resolve critical issues

+ Facilitate the implementation and execution of labeling changes from initiation to first shipment with changed labeling per pre-established SLA (service level agreements), track timelines and provide status updates to stakeholders

+ Lead the execution of labeling operations process and build any existing and moderately complex NPD change package deliverables (e.g., process redlines, document management processes

+ Lead process improvement projects

+ Provide routine labeling guidance and build sustainable relationships and collaborative communication with BU cross-functional stakeholders

**Job Requirements:**

+ Bachelor's Degree (BS) with 3 Years experience medical / pharmaceutical FDA regulated industry Required

+ Good computer skills including usage of MS Office Suite

+ Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and

+ relationship management skills

+ Good leadership skills

+ Experience managing tasks of projects

+ Able to read, comprehend, write, and speak English

+ Moderate understanding of domestic and global development and implementation of labeling

+ Moderate understanding of medical and/or pharmaceutical regulations and standards

+ Moderate knowledge of medical device documentation development activities

+ Knowledge of Change request processing, Product data management (PDM) process

+ Good computer skills including usage of MS Office Suite

+ Good problem-solving, organizational, analytical and critical thinking skills

+ Basic project management skills

+ Strict attention to detail

+ Ability to build productive internal/external working relationships

+ Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

**For immediate consideration, apply today! Questions? Call Toni at 714.454.8252 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: 2019-07-29 Expires: 2019-08-29

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Quality Assurance / Labeling Specialist - Irvine, CA

Kelly Services
Irvine, CA 92604

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