Final Release Specialist - 2nd Shift

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

Job Purpose

The Final Release Specialist II supports the batch final release processes and performs functions necessary to ensure that all relevant manufacturing records and documentation are assembled, reviewed, and completed in a compliant efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable requirements. This is a second shift role with the hours of Monday through Friday, 3pm - 11pm.

Key Responsibilities

• Maintain the flow of work, to include but not limited to, the setup of technical records for review, inspection,
• Assign and track to completion all work in progress (WIP) records.
• Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution, Engineering and all other cross functional departments to ensure commitments and customer needs are met.
• Knowledgeable in ERP and QMS electronic systems
• Able to identify and initiate nonconformances.
• Responsible for the QA review of data entry, documentation, and technical and final release records.
• Ensure that each batch is inspected per specification, physical product is verified prior to setting final disposition.
• Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations.
• Communicates with appropriate personnel on missing required documentation, error corrections required.
• Responsible for reporting QA variances, errors and deviations on all initiated documentation to Quality Assurance Department.
• Organizes the flow of records through Final Release, working with Program Managers to prioritize and provide turnaround times.
• Develops and releases controlled work instructions on the Final Release process.
• Identifies opportunities for improvement both in the Final Release process and inputs to the Final Release process.
• Works closely with area stakeholders that are inputs to the Final Release process to resolve issues. Develops strong working relationships and operates in a team structure.
• Performs other duties as assigned by the Manager and Director of the Department.

Qualifications

• 3+ years of experience in Med Device Manufacturing with direct responsibility for Final Release or Document Control.
• Proficiency in reading and interpreting engineering drawings, blueprints, and technical specifications.
• Demonstrated experience reviewing Device History Records (DHRs) and Batch Records for completeness and compliance.
• Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate’s skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The hourly pay range for this position is$22.60-$31. This role shall also include a pay differential of 10% on any applicable shift not included in the standard base-pay shifts.