Job Type

full-time

posted

8 days ago

Location

Norwood, MA

Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Quality Assurance Systems & Distribution Specialist

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Contract to Permanent
  • Pay rate:  $35-40/hr.
  • Job Location:  Norwood, MA
  • Job#: bh12971

 

Specialist, QA Quality Systems and Distribution

We are seeking a Quality Assurance (QA) Specialist for a position based at their Norwood, MA facility. The individual in this role will be responsible for providing QA Quality System support for our Clinical Drug Supply Chain packaging, labeling and distribution operations based in the US. The individual will primarily work with: Supply Chain Operations, Logistics, External Manufacturing, Global Quality, CMC and external network partners involved in distribution of our commercial product. This individual will manage quality systems, procedures and workflows for our outbound commercial supply chain from secondary packaging through to the customer in our US-based distribution network. This individual may also provide Quality Assurance support of shipment validation and qualification activities related to cold chain and/or distribution. The preferred candidate would have experience in a biotech or pharmaceutical GMP environment, with some cold chain experience.

This role would report to the Associate Director of Quality Assurance or Sr. Manager, QA Quality Systems and distribution and will be responsible for quality systems in our clinical packaging, labeling and distribution supply chain based out of the US.

  • Support quality systems related to our US-based distribution network including domestic and international shipping lanes with oversight
  • Support validation activities for shipping lanes and cold chain qualification of materials and equipment in our supply chain including secondary packaging and distribution vendors
  • Initiate quality events for quality system workflows related to shipping events including cold chain excursions
  • Support closure of quality systems at commercial secondary packaging CMOs
  • Assist in quality oversight of distribution partners
  • Assist in developing procedures to optimize quality compliance within third party distribution vendors
  • Track distribution related quality metrics
  • Initiate investigation requests for supplier corrective actions at US-based distribution vendors as appropriate
  • Initiate CAPA’s to drive proactive initiatives for continuous improvement
  • Maintain trackers and Report temperature excursion data back to internal partners
  • Maintain metrics for key quality performance indicators for cross-functional visibility
  • Support Supply Chain Quality Deliverable timelines and escalate issues in a timely manner
  • BS in a scientific or engineering discipline with 4+ years of experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
  • Effective communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
  • Experience working in quality systems including deviations, change controls and CAPA
  • Experience with cold chain
  • Proficiency in Microsoft Office tools including PowerPoint, MS Project and Visio

Previous experience in a GMP environment is required

Please use the apply buttonto submit your resume for consideration.  A Connexion Representative will contact you immediately.

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About the Company

Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering

Connexion Systems & Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

Company Size

500 to 999 employees

Industry

Staffing/Employment Agencies

Founded

1999

Website

https://www.csetalent.com/