Advanced Bio-Logic Solutions Corp.

Specialist Quality Control

Advanced Bio-Logic Solutions Corp.  •  $39/hr  •  Thousand Oaks, CA (Onsite)  •  3 months ago
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Job Description

Location: Onsite - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $39/$50 per hour (based on experience)

of the Role

Serve as a System Administrator supporting business processing environments for a big biopharma leader. Oversee installation, configuration, and maintenance of operating systems, servers, and layered products while ensuring compliance. Troubleshoot technical issues, schedule system upgrades, and play a key role in the validation and deployment of GxP laboratory systems in regulated environments.

Key Responsibilities

  • Install, configure, and maintain operating systems, servers, and ancillary products with compliance to licensing and maintenance agreements
  • Troubleshoot, respond to escalations, and perform hardware or software repairs as needed
  • Schedule and oversee hardware and software installations and upgrades
  • Participate in process engineering activities and facilitate new business SOPs, forms, and manuals for evolving electronic workflows
  • Participate in system requirement gathering, configuration, and design activities for the new ELN system
  • Verify and manage site master data
  • Coordinate ELN Template development and review with site subject matter experts
  • Support development and review of Operational Qualifications (OQ), User Acceptance Testing (UAT), and Data Migration Verification
  • Contribute to the review and input of training materials, and support instrument qualification activities at the site

Required Experience & Skills

  • Extensive experience with GxP laboratory systems and computer systems validation, including hands-on IQ, OQ, PQ, UAT, and data migration verification for ELN, LIMS, and LMES platforms aligned with GAMP and 21 CFR Part 11 requirements
  • Proven background in electronic laboratory workflow design, configuration, validation, and deployment for global QC operations in regulated biopharmaceutical environments
  • Strong expertise in quality systems within biopharmaceutical QC environments, including SOP development, deviation and change control management, CAPA support, audit readiness, and inspection defense

Top 3 Must Have Skills

1. GxP laboratory systems and computer systems validation (IQ, OQ, PQ, UAT, data migration for ELN/LIMS/LMES; GAMP; 21 CFR Part 11)

2. Electronic laboratory workflow configuration, validation, and deployment; electronic procedures/templates; global QC support in biopharma

3. Quality systems expertise: SOP development, deviation/change control, CAPA, audit readiness, inspection defense

Day-to-Day Responsibilities

  • Install and upgrade software and hardware components per schedule
  • Troubleshoot escalated technical issues and execute repairs
  • Lead ELN system process engineering and facilitate new business documentation
  • Participate in requirements gathering, system design, and configuration
  • Coordinate with site SMEs for ELN Template development and review
  • Execute and verify UAT and data migration efforts
  • Review, develop, and support training materials
  • Assist in planning and executing site instrument qualifications

Basic Qualifications

  • Doctorate degree
  • Masters degree and 2 years of experience
  • Bachelors degree and 4 years of experience
  • Associates degree and 8 years of experience
  • High school diploma / GED and 10 years of experience

This posting is for Contingent Worker, not an FTE

Advanced Bio-Logic Solutions Corp.

About Advanced Bio-Logic Solutions Corp.

Advanced Bio-Logic Solutions Corporation (ABL) provides products and services that address the technical infrastructure needs of the life sciences community. Our extensive experience working with biotech, pharmaceutical, and medical device companies allow us to partner with our clients to develop unique solutions that address their organizational objectives.

From inception, ABL has focused on fully understanding our client’s business opportunities and challenges. Our business is founded on the principle that each client has unique requirements, and the most relevant solutions are tailored specifically to that client. We believe that as a technical solutions provider, we bring the most value to our clients when we truly understand what enables them to bring their projects to fruition.

Over the years we have found that the most comprehensive solutions are those that evolve with the client. We offer an array of products, and services that allow customers to partner with ABL where it is most relevant to them. Whether it be the skills and experience obtained by bringing talent “in-house” through contract or full time placements, or the benefit of outsourcing critical data projects that require rapid development cycles, ABL will tailor solutions that allow you to spend less time managing internal business functions, and place greater emphasis on your core business objective: revenue generating activities.

Industry
Unknown
Company Size
11-50 employees
Headquarters
Westlake Village, CA
Year Founded
2002
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