Quality and Validation Analyst- Serialization-Biotechnology - PharmEng Technology - Jersey City, NJ

Company Description
PharmEng Technology is an international full service consulting firm that services pharmaceutical, biotechnology, medical device, nutraceutical, heath care and chemical sectors. PharmEng Technology has a proven track record of excellence which ensures all of client needs and governing regulatory expectations are met and exceeded.

PharmEng Technology provides services in:

-Commissioning & Qualification
- Validation (Manufacturing, Lab)
- Quality systems
- Engineering
- Regulatory Affairs
- Training/Teaching

As a fast pace fast growing consulting firm we are always looking for qualified scientists and engineers with the ability to create and communicate innovative and cost effective solutions to clients. This is a great opportunity to obtain a challenging career that enables you to work closely with major international clients and travel the world!

We currently have projects all over the world in Canada, USA, Europe and Asia.

Job Responsibilities:
The individual will be a subject matter expert in Quality Assurance and will be responsible for Quality documentation and deliverables for the Serialization Program. Working closely with the Quality functional lead and Program manager, the Quality analyst will develop the Quality Plan for Serialization, Release, Distribution and Tracking of commercial finished goods and populate Change Controls in Trackwise with project information. In addition, the Quality Analyst will facilitate and develop an FMEA Risk Assessment on the end-to-end serialization design.
Specific areas of responsibility for the Quality Plan include:

  • Document QA activities necessary to support Supply Chain Management and IT initiatives
  • Summarizes the documents, controls and QA activities necessary to ensure the compliance of a serialized product
  • Set up Change Control via Trackwise. Transcribe project plan content into Trackwise action plans.

Specific areas of responsibility for the Risk Assessment include:

  • Manage and facilitate the process of risk assessment with project team members
  • Follow our client’s Procedure for Process Risk Assessment to insure all aspects of risk have been properly analyzed
  • Research and assess risk assessments developed by vendors and partners
  • Produce Failure Mode and Effects Analysis (FMEA) report detailing the documented study, prioritizing risks and identifying mitigation plans.

Minimum Qualifications:

  • A minimum of 5-10 years’ experience managing complex projects along with a working knowledge of contract manufacturing and distribution operations in the Pharmaceutical or Biotechnology industry is required.
  • Facilitating risk assessments
  • Experience in writing Quality Plans for medical devices
  • Serialization knowledge and experience
  • Working in global environment
  • Working in the area of Operational Excellence
  • Pharmaceutical supply chain experience
  • Lean sigma brown or black belt, or hazard study leader preferred
  • Track wise experience preferred
  • Effective communicator

Other requirements:
Willingness to travel, Hold a valid driving license and passport, Must be able to legally work in USA.

Thank you for your interest in our organization. Only those selected will be contacted. No Phone calls please.

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