Position Summary:

• 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:

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

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

3. 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