3 days old

Quality Specialist

Kelly Services
Shepherdsville, KY 40165
Kelly Services is currently seeking a Quality Specialist in Shepherdsville, KY to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the** Quality Specialist **includes:**

The Quality Specialist role is to execute the Quality Assurance operation functions as they relate to cGMP activities and enforce quality assurance standards and measures for equipment, systems, processes and product within the Louisville Distribution Center and the organization. In addition to directly supporting receipt, storage, release and distribution of product and raw materials, this individual may provide QA support to the site document management, auditing, change control, complaints, investigations, training, validation, metrology, and supplier/vendor management programs. Some off-hour work may be required during peak processing times.

The Quality Specialist is responsible for:

Support site compliance to procedures and policies for all operations at the site

Provide direct QA support for deviations (including supporting development of corrective/preventative actions)

Review / assess critical-to-quality data related to distribution

Support, execute, and/or review document, process, facility change controls

Support the collection, management, and reporting of site quality metrics

Assist response to product complaints that are possibly related to receipt, storage and distribution activities associated with the site

Assist generation of Annual Product Review documents.

Support and provide key participation in internal and Regulatory Inspections

Participate in interdisciplinary Projects as required

Support site document management / records archive system

Support site GMP supplier quality

Support site self-inspection and external audits

Support quality responsibilities for material controls / status controls

Support corporate quality initiatives

Other Responsibilities

Perform a variety of work in enterprise applications, such as Excel, PowerPoint, Word, MS Project, Visio, SAP, Trackwise, Aegis, and Minitab/JMP.

Enforces compliance with local, DOT, FAA, OSHA, AstraZeneca, AstraZeneca Biologics (MedImmune) and all other applicable regulations.

Minimum Requirements:

High School Diploma or Associates Degree (QA I) / Bachelors Degree (QA III)

0+ years (QA I) / 3+ years (QA III) experience in the Biopharmaceutical/ pharmaceutical industry.

0+ years (QA I) / 3+ years (QA III) experience in quality assurance, quality control, or validation.

Excellent communication and positive interpersonal skills

Excellent writing skills

Familiarity/proficiency with electronic applications (e.g. MS Word, Excel, etc.)

Ability to adapt to a changing environment, able to set and adjust priorities accordingly

Capable of functioning independently with minimum of supervision/direction

QA II and above: Experience working in a highly regulated environment (FDA, EMA)

Preferred Background:

(QA III) Bachelors (BS) degree (or higher) in biology, chemistry, engineering or other related technical field is preferred

Knowledge of supply chain principles: GMP, GDP, Regulatory.

Working knowledge of Quality Information Systems (e.g., Trackwise) and Enterprise Resource Planning systems (e.g., SAP)

QA on the Floor / Auditing experience

GMP Distribution experience

GMP (or device or ISO) Quality Systems

Project management skills

**Education and Experience Requirement of the** Quality Specialist **includes** :

+ Bachelors (BS) degree (or higher) in biology, chemistry, engineering or other related technical field is preferred

**Additional Information:**

+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.

**Kelly Temporary Employee Perks:**

+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts

**Apply Now!**

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Please email your resume directly to Sandy at: [reference BH Job #3071685]

Thank you for your interest in the assignment.

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-09-14 Expires: 2020-10-15

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Quality Specialist

Kelly Services
Shepherdsville, KY 40165

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