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QA CSV Specialist

Location: Philadelphia Area

Job Description

At Azzur, we are looking for personnel, who live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverable of any given project. The level of knowledge expected will be commensurate with level of incoming experience.


Essential Duties and Responsibilities

  • Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
  • Perform (hands on) field execution of commissioning and/or validation documentation
  • Responsible for working with all team members to ensure timely delivery of project requirements (schedule, budgets, and costs). Ensure project team members work within the project schedule and budgets. Provide updates to client and management indicating status of project as required.
  • Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures


Qualifications

  • Minimum 3-5 years’ CSV and Qualification documentation of IQ, OQ, PQ and independent quality review experience in the pharmaceutical, Medical industry and/or biotechnology industry is required.
  • Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
  • Experience with Software Validation with Laboratory Information System (LIS).
  • Experience with following instruments. like i. Diasorin Liaison MDX Software ii. QuantStudio 5 & 7 Application Software V1.3 iii. QuantStudio COVID-19 Testing Interpretation Software V2.3 iv KingFisher
  • Experience with Interface Validation eg Instrument to LIS, LIS to Billing System, LIS to State reporting System.

Education:

Bachelor degree or M.Sc. in Science, Biology, Microbiology, Biotechnology or Biochemical Engineering.

 

Benefits

Who we are:

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!

 

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.


Apply Now
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