8 days old

Quality Assurance Specialist

Kelly Services
Landing, NJ 07850
**Quality Assurance Specialist**

**Direct Hire/Salaried**

**Landing, NJ**

**Responsibilities include:**

+ To check ALL goods received are not falsified medicines, by looking for evidence of tampering or anything suspicious. Check product description, quantities, expiry dates, batch numbers are accurately recorded and match the relevant purchase orders.

+ To ensure goods that have been delivered by bona fide suppliers are to a high standard.

+ To ensure goods are supplied to customers who are bona fides.

+ To ensure goods that are damaged are returned to the supplier or destroyed by the appropriate contracted company following the companys returns and or destruction procedures.

+ Work within internal stock control system Orderwise and ensure goods are booked in accurately and in a timely manner.

+ Ensure the conditions of the New Jersey State Board Wholesale Distribution Authorization are met.

+ Check that Warehouse and Cold Room temperatures are kept correctly on a daily basis

+ Support warehouse and cold room seasonal temperature mapping studies.

+ Ensure that Standard Operating Procedures (SOPs) are up to date and reviewed on a regular basis.

+ Support the introduction of new SOPs when required.

+ Support with deviation and complaint investigations and implementation of CAPAs.

+ Support the change control process

+ Liaise with the New Jersey State Board and or FDA as and Host New Jersey State Board inspections and client audits.

+ Check that the temperature probes are serviced and calibrated annually and records kept.

+ To train staff ensuring that they are fully competent in the local processes and all SOPs.

+ To ensure that operations do not compromise product quality and patient safety.

+ To ensure that documentation is kept for at least 5 years from the point of generation.

+ To ensure full and prompt cooperation with marketing authorization holders in the event of recalls.

+ To oversee audit of the quality system and to carry out sufficient number of self-inspections.

+ Responsible for supplier and customer qualification prior to sourcing or supplying.

+ Performing on-site audit of suppliers as part of the supplier qualification process where necessary

+ Support appropriate levels of validation and qualification of equipment and computer systems

**Requirements** .

+ Bachelor's degree in a Science field or a related field strongly preferred. Or equivalent work experience with a minimum of a High School Diploma.

+ 2 to 3 years experience with FDA-regulated operations and Quality Assurance

+ Must have experience with cGMP guidelines and good documentation practices.

+ Experience in a warehouse & logistics capacity.

+ Database and operational experience with stock control systems.

+ Demonstrated experience and understanding of courier companies processes.

+ Can conform to shifting priorities, demands and timelines through analytical and problem-solving.

This role reports to the Commercial Director, Overtime may be required from time to time to meet project deadlines. You must be able to work under own initiative and as part of a team. We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.

**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-06-07 Expires: 2021-07-08

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Quality Assurance Specialist

Kelly Services
Landing, NJ 07850

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