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Senior 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

  • Leads and manages qualification sub-team to engage with internal and client teams and to ensures deliverables are met on time. Operates using independent judgement and discretion with little oversight.
  • Apply theory, technical principles and judgement to address a broad range of project/equipment/process challenges.
  • Act as a senior technical resource and guide to junior members of the team, working with cross-functional teams to determine technical solutions for manufacturing/QC qualification activities
  • Consolidate and manage process knowledge, serving as a single point of contact for information related to QC and Manufacturing equipment qualification activities and requirements
  • Participate in scope definition/control for qualification activities as appropriate, coordinating efforts between client and consultants on site.
  • Responsible for ensuring manufacturing and QC equipment are qualified to required standard. Review and interpret data for accuracy for completed qualification activities to ensure requirements and acceptance criteria are met. Prepare report packages by analyzing and summarizing data to support test and protocol requirements. Manage troubleshooting efforts for protocol discrepancies.
  • Develop project plans with input from key stakeholders
  • Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
  • 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 7-10 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.



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