Project Engineer/Document Turnover Specialist

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

All Jobs > Project Engineer/Document Turnover Specialist

Requirements

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

Experience / Skills

• Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical field; equivalent GMP industry experience will also be considered.
• 1–3 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related life sciences environment.
• Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and data integrity principles (ALCOA+).
• Experience reviewing controlled GMP documentation such as batch records, validation documentation, laboratory records, or quality system records.
• Familiarity with Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), or similar regulated documentation platforms.
• Strong organizational, communication, and problem-solving skills with exceptional attention to detail and the ability to manage multiple priorities.
• Self-motivated with the ability to work independently, collaborate across functional teams, and consistently meet deadlines in a fast-paced GMP environment.

Benefits & Compensation

• Industry competitive wage as a full-time employee
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

About Alliance Biotech Solutions

Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.

Alliance Biotech Solutions is an Equal Employment Opportunity /Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.

All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.