QC Associate Scientist - Sample Management, GMP, SOPs in Warren, NJ at APEX Systems

Date Posted: 2/12/2020

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Warren, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    2/12/2020

Job Description

Job #:  1048061


QC Sample Management Associate (LIMS, cGMP, GLP, GDP)

Apex Systems is seeking a QC Sample Management Associate responsible for the movement of samples and materials in support of the Quality Control laboratories. This includes sample collection and distribution, inventory control, maintaining chain of custody and sample tracking. Working in a regulated environment following current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs) and aseptic techniques.
 
Responsibilities
  • Responsible for movement of QC biological test samples including receipt, storage, distribution, transfer, and disposal
  • Maintain sample tracking and chain of custody records in accordance with cGMP requirements and written procedures
  • Ensure that expired samples/materials are destroyed/disposed of according to written procedures
  • Performs sample queries and periodic storage reports as required
  • Assist management with investigations and deviations related to sample management
  • Collaborate with teams to identify and implement process improvements
  • Support sample management metrics
  • Facilitate cold-chain sample transfers as required
  • Assist with maintaining an inventory of lab supplies, reagents, media, consumables, etc.
  • Liaise with supply chain, warehouse, and lab services to ensure supply stocks
  • Ensure that materials are appropriately labeled and traceable as per appropriate cGMP, regulatory requirements, and written procedures
  • Assist management with investigations and deviations related to lab inventory
  • Maintain 5S and FIFO principles as appropriate

 
Qualifications:
  • Bachelor’s (BS) Degree required; preferably in a Science related field
  • 2+ years of relevant work experience; preferably in a regulated cGMP environment. GMP, GLP, GDP, Compliance
  • Experience with LIMS sample management system; or equivalent is helpful
  • Excellent documentation, computer, inventory and interpersonal skills required for this collaborative role
  • Experience with sample storage and transfers
  • Experience with Microsoft Word, PowerPoint, Excel is helpful
  • Ability to don appropriate gowning and work in a classified cleanroom environment
  • Ability to work in a collaborative team environment
  • Prior experience and ability to follow and apply Global Regulatory and cGMP requirements
  • Ability to adapt and adjust to changing priorities and to meet deadlines
  • Ability to follow, review and revise SOPs
  • Ability to work on weekends or weekdays with flexible shift hours to support a 7 day a week Manufacturing operation

 
FOR IMMEDIATE CONSIDERATION Please:
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.