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Laboratory Applications Specialist - East Coast, US, United States



United States, Italy 

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Job Description:

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of over 350 dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide.

An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.

Due to a constant growth, PQE is looking for two Laboratory Applications SMEs working either at Clients sites or in its office based in Rockville, MD.

Responsibilities include, but are not limited, to the followings:

  • Assessment of Laboratory Systems with respects to instrument qualification and computer system validation
  • 21 CFR Part 11 compliance Gap Analysis
  • Laboratory Systems configuration
  • Compliance Data Analysis and Historical Data Review

Experience Required

  • 5 + Years of LAB Applications Experience
  • Around 5-6 years of experience in CDS specifically Empower and Chromeleon
  • Hands on experience on patch updates, workflow configuration e.g. Standard/Reagent, Test methods, Sampling, Testing and results, Approvals, Instruments etc.
  • Experience of operating under strict cGXP environment, interacting with IT System Owners and business end users.
  • Excellent oral and written communication skills.
  • Bachelor’s / Master’s Degree in Chemistry/Biology/Biotechnology
  • IT experience with exposure to Life Sciences / Pharma projects

Location: Rockville, MD and East Coast Sites

Job Type: Full-time

Candidates must have strong technical knowledge regarding Laboratory Systems and have demonstrated successful customer service performance.

Proven capability of effectively collaborating in a Multinational/Multilanguage Team will be considered as a preferential requirement.

We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

Further information can be found at www.pqegroup.com or visit our company page on LinkedIn: https://www.linkedin.com/company/pharma-quality-europe/

Job Type: Full-time

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