Technical Specialist - QC Laboratory Readiness

Job Posting: Technical Specialist - QC Laboratory Readiness (Hybrid Role)

Location: North Carolina (Hybrid with up to 80% onsite support)

Job Type: Long Term Contract

Experience Level: Senior (12 years required, 15 years preferred)

About the Role:

We are seeking experienced professionals for three specialized roles supporting the commissioning and startup of Quality Control (QC) laboratories. These positions involve leading documentation, process implementation, and technical validation to ensure GMP compliance at our facility. The role requires up to 80% onsite support, depending on project needs.

Open Specializations:

1. Analytical Validation & Method Specialist: Extensive experience in method validations, verifications, transfers, material qualifications, and stability studies.
2. Analytical Validation & Quality Risk Assessment Specialist: Combines analytical validation expertise with proficiency in writing Quality Risk Assessments (QRA) for lab sample chain of custody.
3. Sample, Stability, and Reserve Management Specialist: Expertise in sample, stability, and reserve management to assist with process implementation for a new site.

Key Responsibilities:

Technical Documentation:

• Develop, write, edit, and format SOPs, O&M Procedures, Equipment Data Integrity Assessments, protocols/reports for method validations, verifications, and stability studies.
• Ensure documentation adheres to established guidelines and good documentation practices (GDP).

Quality Control Laboratory Readiness:

• Commission and qualify QC laboratory equipment (Chemistry, Bioassay, Raw Material, Microbiology).
• Lead QC Quality Risk Assessments for sample chain of custody and analytical testing.
• Author and process validation protocols, change management documents, and Compendial Verifications.

Process Implementation and Incident Management:

• Implement processes for sample, stability, and reserve management.
• Provide support for incident management, including nonconformances and technical/operational gap resolution.

Collaboration and Reporting:

• Manage document lifecycle updates within electronic Quality Management Systems (eQMS).
• Monitor QC laboratory readiness metrics and provide timely updates.

Ideal Candidate Qualifications:

Experience:

• Minimum 12 years of relevant experience (15 years preferred).
• Extensive experience in QC equipment commissioning and analytical method validation/verification.

Technical Competencies:

• Proficiency in HPLC/UPLC, HPIC, SEC, K-F, TOC, ELISA, cell-based assays, peptide mapping, glycan, and aggregate analysis.
• Familiarity with analytical techniques and sample preparation.

Technical Writing Expertise:

• Previous experience in regulated environments with document version control.
• Proficiency in MS Office and electronic Quality Management Systems (eQMS).

Soft Skills:

• Excellent communication and technical writing skills.
• Ability to identify technical/operational gaps and propose solutions.

Why Join Us?

Be part of a dynamic team working on cutting-edge QC laboratory projects, contributing to the development of state-of-the-art facilities. This is a unique opportunity to leverage your expertise in a highly collaborative and innovative environment.