ELN Lab Associate Job at SPECTRAFORCE, West Greenwich, RI

bnBSTlRuMFVLWUZaZmhLdTgvS1NaNEg4S3c9PQ==
  • SPECTRAFORCE
  • West Greenwich, RI

Job Description

Job Title: Quality Control Senior Associate

Location: West Greenwich, RI, 02817

Duration: 1 year (Possibility of Extension)

Type of Job: Hybrid - (Estimated 3 days per week onsite, up to 5 days as needed)

Overview:

This position is responsible for executing deliverables related to the implementation of Amgen's new, fully Electronic Lab Notebook (ELN) system under BPO supervision. It is a non-laboratory testing position focusing on the design, configuration, and validation of the new ELN system, data migration, and deployment of production instances at various sites. The role requires adherence to established procedures (Standard Operating Procedures, Work Instructions) for safety, cGMP, and CFR requirements.

Key Responsibilities:

  • Process Engineering Activities: Participate in process engineering tasks to support ELN system implementation.
  • Documentation Development: Facilitate the creation of new business SOPs, forms, manuals, and other related documentation using new processes and workflows.
  • System Configuration and Design: Participate in system requirements, software configuration, and design activities.
  • Master Data Verification: Receive and/or verify master data for the site(s).
  • ELN Template Development: Coordinate the development and review of ELN templates with site Subject Matter Experts (SMEs).
  • Operational Qualification Support: Support the development and review of Operational Qualifications (OQs).
  • User Acceptance Testing (UAT) & Data Migration Verification: Execute UAT and verify data migration processes.
  • Training Support: Review and provide input on training materials; support the development of training materials by providing necessary reviews.
  • Instrument Qualification Support: Support site instrument qualification activities, including planning and execution.

Ideal Candidate:

  • Education: Bachelor's degree with 2+ years of experience in quality control, or equivalent experience.
  • Experience: Minimum of 2 years of experience in quality control or a related field, particularly in regulated environments.

Skills:

  1. GxP experience, specifically in the testing of biopharmaceuticals.
  2. Experience in the development and validation testing of software used in GMP environments.
  3. Experience with electronic lab notebook systems (e.g., Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
  4. Experience with other industry systems such as Veeva & Empower.
  5. Knowledge of analytical methods and processes.
  6. Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
  7. Strong problem-solving capabilities and attention to detail.
  8. Proven ability to collaborate within and across functional areas.
  9. Excellent written and verbal communication skills.

Basic Qualifications:

  • Education: High school/GED with 2 years work experience, OR Associates degree with 6 months of work experience, OR Bachelor's degree.

Job Tags

Work experience placement, 3 days per week,

Similar Jobs

Insight Global

Technical Writer Job at Insight Global

 ...Day to Day: A client of Insight Global is looking for a Technical Writer to join their Change Management team. This team plays a crucial role in communicating organizational changes resulting from the migration from an existing ERP system to SAP. As a Technical Writer... 

WSN

Project Manager Job at WSN

WSN is hiring a Project Manager/Business Analyst to join a global investment bank in Getzville/Buffalo on a contract basis. Project Manager / Business Analyst Team/Role Overview: The Operations Optimisation and Enablement team (OOE) sits within the Operations...

Carroll Construction Supply

CDL Driver Job at Carroll Construction Supply

 ...Gretna Driver CDL Driver Needed Carroll Supply Gretna is looking...  ...drivers to drive our one-ton truck pulling a 30 gooseneck...  ...a big part in our day-to-day operations as they heavily work with others...  ...states. Do you want to be a part owner of a growing successful... 

Richmond International Forest Products

2025 Summer Intern Job at Richmond International Forest Products

 ...Jumpstart your career with Richmond International Forest Products (RIFP), a leading commodities trading company in the wood products industry...  ...and demonstrating curiosity At RIFP, we aim to develop and cultivate strong relationships with our interns that extend... 

Indigo Wild

Warehouse Specialist Job at Indigo Wild

Indigo Wild, the proud maker of Zum, was founded in 1996 by Emily Voth, who first created bath products in her kitchen. Now, 2.5 million Zum Bar Soaps are sold every year! We craft extraordinary products with ingredients that matter and scents that tell a story, to transform...