Assurance Specialist – Quality Documentation & SDLC

Alphanumeric; Lower Providence Township (PA); Hybrid; USD 56,000 - 62,000; Full time

Job summary

Alphanumeric is seeking an Assurance Specialist to support quality documentation and SDLC processes in a regulated technology environment. You will manage controlled documents, coordinate reviews, and ensure audit-ready records.

The role emphasizes collaboration with Quality, Engineering, and global stakeholders, with hybrid onsite work and a focus on maintaining compliant, traceable documentation across the SDLC.

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• Approximately 3-5 years of relevant experience in quality documentation, document control, or a related compliance-focused role.
• Hands-on experience managing controlled document lifecycles within a QMS / eQMS environment.
• Working knowledge of SDLC including Agile, Scrum, or waterfall methodologies.
• Experience supporting SDLC documentation such as requirements, specifications, tests, or release docs.
• Proficiency with document repositories and version control tools (e.g., SharePoint, Confluence, Jira).
• Strong technical writing, proofreading, editing, and formatting skills.
• Experience coordinating document reviews and approvals across multiple stakeholders.
• Familiarity with quality risk tracking, CAPAs, deviations, and audit readiness.

Responsibilities

• Support end-to-end documentation lifecycle for engineering activities.
• Coordinate with Quality, engineers, and stakeholders to obtain docs and secure timely approvals.
• Review technical documentation for accuracy, clarity, formatting, and completeness.
• Maintain controlled documentation repositories and version histories for traceability.
• Track deliverables, approvals, and actions to meet deadlines.
• Assist with CAPAs, risks, incidents, and related records.
• Support SDLC documentation including requirements, specs, testing, and release docs.
• Coordinate document routing, uploads, and finalization in QMS systems.
• Provide regular progress updates and elevate documentation or compliance concerns.
• Collaborate with cross-functional teams including international stakeholders.

Skills

Quality documentation

SDLC understanding

Document control

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in a scientific discipline or related field

Tools

Jira

Confluence

SharePoint

Job description

Make Your Mark with a Job at Alphanumeric

Job Details

Assurance Specialist – Quality Documentation & SDLC Collegeville,PA Posted:10/14/2026 Job Description Job ID#: 8429

Assurance Specialist - Quality Documentation & SDLC

Location: Upper Providence, PA
Work Arrangement: Hybrid - Onsite approximately once per week or every other week
Schedule: Monday-Friday | 8-hour day shift Hourly Pay:$41.00-45.00
Experience Level: Mid-Level (3-5 years preferred)

About the Opportunity

We are seeking a detail-oriented Assurance Specialist to support quality documentation, document lifecycle management, and compliance activities within a regulated technology and life sciences environment. The ideal candidate will bring a combination of quality documentation experience and working knowledge of the Software Development Life Cycle (SDLC). This position focuses on maintaining accurate, controlled, and audit-ready documentation while collaborating with Quality, Engineering, and cross-functional stakeholders. This is a hands-on coordination and documentation support role, well-suited for a professional who enjoys managing details, maintaining compliance, and ensuring documentation progresses efficiently through established review and approval processes.

Key Responsibilities

• Support the end-to-end documentation lifecycle for engineering activities, including document creation, review, approval, version control, and retention in accordance with established quality processes.
• Coordinate with Quality team members, engineers, and other stakeholders to obtain documentation, facilitate reviews, and secure timely approvals.
• Review technical documentation for accuracy, clarity, formatting, consistency, and completeness, escalating potential issues to the appropriate Quality team member.
• Maintain controlled documentation repositories and version histories to ensure traceability, compliance, and audit readiness.
• Track documentation deliverables, approval workflows, and outstanding actions, proactively following up with stakeholders to meet established deadlines.
• Assist with tracking deviations, corrective and preventive actions (CAPAs), risks, incidents, and other quality-related records through resolution.
• Support documentation associated with the Software Development Life Cycle (SDLC), including requirements, specifications, testing records, and release documentation.
• Coordinate document routing, uploads, approvals, and administrative finalization within established quality management systems.
• Provide regular progress updates, identify potential delays, and elevate documentation or compliance concerns to the assigned Quality team member.
• Collaborate with cross-functional teams, including international stakeholders, to support consistent documentation practices and quality standards.

Job Requirements

Required Qualifications

• Bachelor's degree in a scientific discipline or related field.
• Approximately 3-5 years of relevant experience in quality documentation, document control, technical documentation, or a related compliance-focused role.
• Hands-on experience managing controlled document lifecycles within a Quality Management System (QMS), electronic QMS (eQMS), or comparable document management environment.
• Working knowledge of the Software Development Life Cycle (SDLC), including Agile, Scrum, or waterfall methodologies.
• Experience supporting or maintaining SDLC documentation, such as requirements, specifications, test records, or release documentation.
• Proficiency with document repositories and version control tools such as SharePoint, Confluence, or validated document management systems.
• Strong technical writing, proofreading, editing, and document formatting skills.
• Experience coordinating document reviews, tracking approvals, and following up with multiple stakeholders.
• Familiarity with quality-related risk and issue tracking, including deviations, CAPAs, or similar records.
• General understanding of computerized systems validation concepts and documentation requirements.
• Awareness of information security and cloud security principles, including access controls, confidentiality, and data classification.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, prioritize competing deadlines, and escalate issues appropriately.

Preferred Qualifications

• Experience supporting quality documentation in pharmaceutical, biotechnology, life sciences, or another regulated industry.
• Familiarity with 21 CFR Part 11, EU Annex 11, or GAMP 5 guidelines.
• Experience using Jira, Confluence, or comparable project and documentation management tools.
• Understanding of computerized systems validation (CSV), qualification processes, and risk-based validation approaches.
• Familiarity with Governance, Risk, and Compliance (GRC) concepts.
• Experience collaborating with international or UK-based teams.
• Availability to work primarily during Eastern Time business hours to facilitate cross-functional collaboration.

What Makes a Successful Candidate?

The successful candidate will be organized, proactive, and comfortable coordinating documentation across multiple teams. They will understand the importance of controlled documentation in regulated environments and possess sufficient SDLC knowledge to recognize and support software-related documentation requirements. This position is particularly suited for someone who enjoys hands-on documentation management, stakeholder coordination, and quality support rather than primarily strategic leadership or highly specialized validation engineering.

Additional Requirements

• Work Authorization: Applicants must be legally authorized to work in the United States without employer sponsorship, now or in the future.
• Third-Party Submissions: We are not accepting applications or candidate submissions from third-party staffing agencies, vendors, or consulting firms.
• Candidates must be able to meet the hybrid onsite requirements in Upper Providence, PA.