Quality Control - Quality Assurance - Electronic Lab Notebook

Company: Collabera
Location: Thousand Oaks
Posted on: May 23, 2025

Job Description:

Position Summary:

In order to make an application, simply read through the following job description and make sure to attach relevant documents.

We are seeking a detail-oriented and collaborative QA Specialist to support the implementation of a new Electronic Lab Notebook (ELN) system within a cGMP-regulated environment.
The ideal candidate will have a solid background in GxP practices, experience with ELN systems, and a strong understanding of software validation within the pharmaceutical or biotechnology industry.
This role will work closely with cross-functional teams across the organization to ensure compliance, system readiness, and successful rollout of the ELN platform.
The position requires adherence to established procedures (SOPs, Work Instructions) and documentation practices aligned with cGMP and CFR requirements.

Pay range: $27 - $31 an hr.

Key Responsibilities:

Collaborate in process engineering activities to support ELN implementation


Facilitate the development of new business SOPs, forms, manuals, and workflows


Participate in system requirement gathering, software configuration, and design reviews


Verify and manage master data for site-specific needs


Coordinate ELN template development and reviews with site Subject Matter Experts (SMEs)


Support the creation, review, and execution of Operational Qualifications (OQ)


Execute User Acceptance Testing (UAT) and Data Migration Verification tasks


Provide input and review training materials to support user adoption


Assist in developing training content by offering technical and procedural insights


Support instrument qualification planning and execution in alignment with ELN integration



Qualifications:

Minimum Education & Experience:

High School Diploma/GED with 2+ years of work experience


Associate Degree with 6+ months of experience


Bachelor's Degree in a relevant scientific or technical field



Top 3 Must-Have Skill:

GxP Experience - In-depth knowledge of regulatory practices and quality expectations in biopharmaceutical testing


Software Validation - Hands-on experience with validation of software systems in a GMP environment


ELN System Proficiency - Practical experience with one or more ELN systems such as Biovia OneLab, ThermoFisher Sample Manager, LabWare, or Benchling


Additional Preferred Skill:

Strong understanding of data integrity and compliance in laboratory systems


Ability to work both independently and collaboratively in a fast-paced, team-oriented environment


Effective written and verbal communication skills


Familiarity with instrument qualification processes

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