SDLC Quality Documentation Specialist | Hybrid

Alphanumeric Systems; Collegeville (PA); Hybrid; USD 85,000 - 94,000; Full time

Job summary

Alphanumeric Systems is seeking an Assurance Specialist to support quality documentation, document lifecycle management, and SDLC compliance in a regulated technology and life sciences setting. The role emphasizes maintaining audit-ready documentation and collaborating with Quality, Engineering, and stakeholders.

The ideal candidate will have 3–5 years of experience in quality documentation and a solid understanding of SDLC processes, with strong writing and coordination skills to ensure timely

Qualifications

• 3–5 years of relevant experience in quality documentation and document control.
• Experience managing controlled document lifecycles in a QMS/eQMS environment.
• Knowledge of SDLC including Agile, Scrum, or waterfall.
• Proficiency with document repositories and version control tools.
• Strong technical writing, proofreading, and formatting skills.
• Experience coordinating reviews and approvals with multiple stakeholders.
• Familiarity with quality risk tracking, deviations, and CAPAs.
• Understanding of CSV concepts and regulatory documentation requirements.
• Awareness of information security and data classification.

Responsibilities

• Support end-to-end documentation lifecycle for engineering activities.
• Coordinate with Quality and engineers to obtain docs and secure approvals.
• Review technical docs for accuracy, clarity, and consistency.
• Maintain controlled document repositories and version histories.
• Track deliverables, workflows, and deadlines; follow up with stakeholders.
• Assist with deviations, CAPAs, risks, and incident records.
• Support SDLC documentation: requirements, specs, tests, releases.
• Coordinate document routing, uploads, and approvals in QMS.
• Provide progress updates and escalate concerns to Quality.
• Collaborate with international teams to maintain documentation standards.

Skills

SDLC knowledge

Quality documentation

Document coordination

Technical writing

Attention to detail

Education

Bachelor's degree in a scientific discipline

Tools

SharePoint

Confluence

Jira

Job description

Alphanumeric Systems is seeking an Assurance Specialist to support quality documentation, document lifecycle management, and SDLC compliance in a regulated technology and life sciences setting. The role emphasizes maintaining audit-ready documentation and collaborating with Quality, Engineering, and stakeholders.

The ideal candidate will have 3–5 years of experience in quality documentation and a solid understanding of SDLC processes, with strong writing and coordination skills to ensure timely