2nd-Shift Final Release Specialist — QA & Records

VulcanForms Inc.; Harvard (MA); On-site; USD 32,000 - 43,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

401(k) with company match

Paid time off

Job summary

VulcanForms Inc. seeks a Final Release Specialist II to support batch final release, assembly of manufacturing records, and QA review of data and documentation.

This second shift role runs Monday–Friday, 3pm–11pm, requiring attention to SOPs, regulatory requirements, and cross-functional collaboration. Responsibilities include maintaining technical records, reviewing DHRs, identifying nonconformances, and ensuring each batch passes final inspection before disposition.

Qualifications

• 3+ years of experience in Med Device Manufacturing with final release or document control responsibilities.
• Ability to read and interpret engineering drawings, blueprints and technical specs.
• Experience reviewing DHRs and Batch Records for completeness and compliance.

Responsibilities

• Maintain flow of work and set up technical records for review and inspection.
• Assign and track WIP records to completion.
• Attend weekly QA planning meetings with cross-functional teams.
• Identify and initiate nonconformances in a timely manner.
• QA review of data entry, documentation and final release records.
• Ensure batches are inspected per specs and verified before final disposition.
• Review records for SOP, agency and accreditation compliance.
• Communicate missing docs and required corrections to relevant personnel.
• Report QA variances and deviations to Quality Assurance.
• Organize records flow through Final Release and coordinate with managers on turnaround times.
• Develop and release controlled work instructions for Final Release.
• Identify improvement opportunities for Final Release processes.
• Collaborate with stakeholders to resolve issues and maintain team relationships.
• Perform other duties as assigned by the Manager and Director.

Skills

Quality assurance

Documentation control

Attention to detail

Cross-functional teamwork

Tools

ERP

QMS

Job description

VulcanForms Inc. seeks a Final Release Specialist II to support batch final release, assembly of manufacturing records, and QA review of data and documentation.

This second shift role runs Monday–Friday, 3pm–11pm, requiring attention to SOPs, regulatory requirements, and cross-functional collaboration. Responsibilities include maintaining technical records, reviewing DHRs, identifying nonconformances, and ensuring each batch passes final inspection before disposition.