GMP Documentation Project Engineer

Alliance Biotech Solutions; Raleigh (NC); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Employer-paid long term and short term

401k plan with employer contributions

Disability insurance

Job summary

Alliance Biotech Solutions is seeking a Project Engineer/Document Turnover Specialist in Raleigh to ensure GMP documentation is complete, accurate, and inspection-ready. You will coordinate turnover to QA, resolve data discrepancies, and maintain trackers across EDMS and QMS.

The role requires 1–3 years in GMP environments, a Life Sciences/Engineering/Quality background, and strong organizational and communication skills to support commissioning, validation, and batch release activities.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality, or related field; GMP experience considered.
• 1–3 years in GMP-regulated pharma/biotech/medical device environment.
• Familiar with GDP, cGMP, and ALCOA+ data integrity.
• Experience reviewing batch records, validation docs, QA/QC records.
• Proficient with EDMS/QMS and regulated docs.

Responsibilities

• Review manufacturing, laboratory, validation, and equipment documentation for completeness, accuracy, and GDP/cGMP compliance.
• Coordinate turnover of GMP documentation to Quality Assurance, ensuring all records are complete and organized.
• Identify deficiencies, missing signatures, or data discrepancies and resolve issues with cross-functional teams.
• Maintain documentation status trackers and manage records within EDMS and other quality systems.
• Partner with Manufacturing, QA, QC, Validation, Engineering, and Document Control to facilitate document flow and timely package completion.
• Support facility commissioning, qualification, validation, batch release, and audit readiness by ensuring documentation is complete and inspection-ready.
• Participate in CI initiatives to enhance documentation quality, compliance, and process efficiency.

Skills

Attention to detail

Cross-functional collaboration

Documentation management

Time management

Communication

Education

Bachelor's degree in Life Sciences, Engineering, or Quality

Tools

EDMS

QMS

Job description

Alliance Biotech Solutions is seeking a Project Engineer/Document Turnover Specialist in Raleigh to ensure GMP documentation is complete, accurate, and inspection-ready. You will coordinate turnover to QA, resolve data discrepancies, and maintain trackers across EDMS and QMS.

The role requires 1–3 years in GMP environments, a Life Sciences/Engineering/Quality background, and strong organizational and communication skills to support commissioning, validation, and batch release activities.