Compliance Assurance Specialist

Job Description

Job Description

Assurance Specialist - Software Development Lifecycle (SDLC) & IT Quality.

Location: Collegeville / 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/hour W2.

Employment Type: Contract.

Employment Eligibility Requirements:

• No third-party candidates: Applicants must be able to work directly on a W2 basis. Third-party staffing agency submissions, subcontractors, and C2C arrangements will not be accepted.
• Work authorization: Applicants must be authorized to work in the United States without requiring employer sponsorship now or in the future.
• No sponsorship available: Employment-based visa sponsorship is not available for this position.

Position Overview:

Alphanumeric is seeking a detail-oriented Assurance Specialist to support Software Development Lifecycle (SDLC) activities for internally developed software applications within a regulated environment.

This role focuses on coordinating software testing, release activities, change management, and associated documentation while collaborating with software development teams, IT application owners, business stakeholders, and Quality personnel.

The ideal candidate will have practical experience supporting software development processes and an understanding of how internally developed applications move through testing, change control, approvals, and production releases.

This is primarily an administrative and coordination-focused position requiring strong organizational skills, attention to detail, consistent follow-up, and the ability to work effectively with multiple stakeholders.

Candidates should have direct exposure to software development environments rather than experience limited to pharmaceutical manufacturing Quality Assurance or validation of commercially purchased software systems.

Key Responsibilities:

Software Development Lifecycle Coordination:

• Support and coordinate SDLC activities associated with internally developed software applications.
• Track software testing activities, outstanding action items, and completion of required documentation.
• Coordinate with development teams, application owners, and business stakeholders to ensure testing and release-related activities progress according to established timelines.
• Follow up on software testing results, identified issues, and outstanding approvals.
• Support software release activities by coordinating documentation, stakeholder communication, and required approvals.
• Assist with software change management processes, including tracking application enhancements, changes, and associated documentation.
• Maintain accurate records of software lifecycle activities and provide status updates to relevant stakeholders.

IT Quality Assurance and Documentation:

• Support controlled documentation processes associated with software testing, changes, and releases.
• Coordinate document review and approval workflows, ensuring appropriate version control and documentation completeness.
• Track required software Quality records and follow up on missing or incomplete documentation.
• Assist with maintaining traceability between software requirements, testing activities, changes, and release documentation.
• Support Quality reviews, risk assessments, and resolution of documentation or process gaps.
• Ensure established SDLC and Quality procedures are followed and required records are maintained.

Cross-Functional Collaboration:

• Work closely with software development teams, IT personnel, application owners, Quality representatives, and business stakeholders.
• Coordinate meetings, follow-up activities, and action items associated with software testing, releases, and change management.
• Communicate outstanding requirements, documentation gaps, and project status to appropriate stakeholders.
• Help resolve process delays by ensuring required information and approvals are obtained.
• Support continuous improvement of software lifecycle coordination and documentation processes.

Required Qualifications:

• Bachelor's degree in a scientific, technical, computer science, information systems, engineering, or related discipline.
• Professional experience supporting software development lifecycle activities for internally developed or custom-developed applications.
• Working knowledge of software testing, release processes, and software change management.
• Experience coordinating activities, documentation, or approvals involving software development teams and multiple stakeholders.
• Understanding of how software changes progress through testing, review, approval, and deployment.
• Experience maintaining technical documentation, tracking action items, and following up on outstanding requirements.
• Strong organizational, communication, documentation, and time-management skills.
• Ability to manage multiple priorities and work independently while collaborating with cross-functional teams.

Preferred Qualifications:

• Experience in an SDLC coordination, IT Quality Assurance support, application support, software release coordination, or IT project coordination role.
• Familiarity with Agile, Scrum, or Waterfall development methodologies.
• Experience using Jira, Azure DevOps, ServiceNow, or similar tools to track software changes, testing activities, issues, or releases.
• Familiarity with software testing documentation, defect tracking, change requests, and release approvals.
• Experience supporting software development activities in a regulated or compliance-driven environment.
• Knowledge of GxP, computerized system validation (CSV), 21 CFR Part 11, or related Quality requirements.
• Experience with controlled document management systems and formal approval workflows.

Important Candidate Experience Distinction:

This position supports the lifecycle of internally developed software applications and requires practical familiarity with software testing, releases, and change management.

Candidates whose experience is primarily limited to pharmaceutical manufacturing Quality Assurance, routine SOP management, validation of commercially purchased systems, or occasional participation in CSV projects may not possess the required software lifecycle background.

The ideal candidate is someone who understands software development processes and can effectively coordinate documentation, testing activities, changes, releases, and stakeholder follow-up.

This is not a software developer, software engineer, or senior technical project management position.