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Senior Specialist II, QC Lab Systems

Employer
Resilience
Location
East Norriton, PA
Start date
Sep 30, 2022

View more

Discipline
Clinical, Clinical Medicine, Science/R&D, Laboratory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

Relocation Assistance Offered

Position Summary & Role

Resilience seeks a Quality Control Laboratory Systems Administrator, supporting the Quality Control department. The successful candidate will serve as the Laboratory Systems Administrator, performing activities related to analytical laboratory equipment and laboratory information management systems (LIMS) support for the QC organization.

The QC Laboratory Systems Administrator will partner and collaborate with Analytical Development, IT and QC operations teams to ensure that all analytical testing equipment and LIMS meet all partner needs in compliance with standard operating procedures and testing methods.

This position is a first shift role and reports to the Senior Director, Quality Control. The position will be in our East Norrition, PA facility.

Job Responsibilities

  • Own laboratory equipment/systems and LIMS related change controls and CAPAs for QC
  • Serve as system administrator for all QC laboratory equipment/software (i.e. Climet particle counters, BioRad ddPCR equipment, Novatek EM software) and Labvantage LIMS
  • Author, revise and implement all required documentation for both analytical laboratory equipment and LIMS
  • Develop and manage the training for new LIMS users
  • Partner with IT for support related to analytical equipment and LIMS incidents and technical issues to ensure rapid closure
  • Assist in sample receipt/management, including the stability program, within LIMS
  • Other activities as assigned

Minimum Experience, Education & Qualifications

  • BS in relevant discipline (biology, biochemical engineering, computer science, or related field)
  • 8-10 years of experience with implementation and management of LIMS as administrator and / or life science laboratory experience
  • Knowledge of Computer System Validation and 21 CFR Part 11 compliance requirements
  • Experience with a Laboratory Information Management System (preferably LabVantage LIMS) and Quality Management Systems
  • Working knowledge of cGxP regulations, ISO requirements including ICH Guidance’s, GAMP guidance, working knowledge of electronic Quality Management Systems
  • Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated IT experience with some focus on quality operations experience and the ability to collaborate with and effectively influence others
  • Excellent oral and written communication skills

Other Ideal Personal Characteristics:

  • Excellent interpersonal, verbal and written communication skills

#LI-GJ1

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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