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17 days old

QC Inspector

Kelly Services
Horsham, PA 19044
**_Job Title: QC Inspector_**


+ Location: Horsham, PA (100% virtual)

+ Duration: 1 year contract

+ Rate: $30/hr.


*Remote US tri-state location; can be in close proximity to Malvern, PA or Titusville, NJ in the event that worker needs to come on-site by exception*


_Key Responsibilities_


Maintain high-level oversight of all Drug Substance (DS) and Drug Product (DP) lots manufactured throughout the production network

Liaise with samples coordinators at external manufacturers to schedule and execute samples shipments to NCL/OMCLs (National Control Laboratories/Official Medicines Control Laboratories)

Schedule shipping route verification studies and review/approve shipping route verification reports to validate shipping lanes across the network in timely manner

Should samples arrive with alarmed temperature monitor, advise on product disposition

Ensure samples are tracked in eLIMS accurately and in a timely manner

Lead process improvement initiatives to streamline samples sending/receipt processes

Manage process for sending/receiving backup samples as needed

Provide support documentation preparation and submission to health agencies as needed

Complete and pass all applicable training required for access to quality and information management systems (i.e. ETS Trackwise, eLIMS etc.)

Complete and pass all applicable Good Manufacturing Practice training and general quality management training

Learning and remaining current with local regulations, guidelines and quality practices associated with the vaccines industry is required


_Experience / Knowledge Required_


Bachelors Degree in engineering, science, or an equivalent technical discipline

Minimum of 4 years working in an FDA-regulated environment, preferably in a pharmaceutical or biologics manufacturing environment

Basic understanding of of aseptic processing principles

Proficiency in computer applications such as Microsoft Office Suite

Must have strong ability to maintain high efficiencies and accuracy in data entry

Detail-oriented, with ability to quickly process complex information and make critical decisions with limited information at times

Strong interpersonal, written, and oral communication skills


_Experience / Knowledge Preferred_


Experience in the NCL/OMCL process for vaccine government approval/release

Previous experience in work environment under cGMP regulation highly desirable

Experience in Vaccine Production/QA

Proficient in applying process excellence tools and methodologies

Experience working with external manufacturers or laboratories

Advanced degrees are a plus and may reduce the experience required


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-06-07 Expires: 2021-07-15

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QC Inspector

Kelly Services
Horsham, PA 19044

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