Final Release Specialist - 1st shift

VulcanForms Inc.; Harvard (MA); On-site; USD 30,000 - 43,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

401(k) with company match

Job summary

VulcanForms Inc. is seeking a Final Release Specialist II to support batch final release processes and ensure manufacturing records are complete and compliant.

This first shift role runs Monday through Friday, 7am to 3:30pm, with responsibility for QA review and cross-functional coordination to meet customer needs. The ideal candidate has 3+ years in medical device manufacturing focused on final release or document control, with strong skills in reading engineering drawings, DHRs, and CAPA

Qualifications

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

Responsibilities

• Maintain flow of work and set up technical records for review and inspection.
• Assign and track completion of all in-progress records.
• Attend weekly planning meetings as QA representative and coordinate with cross-functional teams.
• Be knowledgeable in ERP and QMS electronic systems.
• Identify and initiate nonconformances.
• QA review data entry, documentation, and final release records.
• Ensure each batch is inspected per specification and verified before final disposition.
• Review and complete records for SOPs, agency requirements, and regulatory standards.
• Communicate missing documentation and required corrections.
• Report QA variances, errors, and deviations to QA Department.
• Organize flow of records through Final Release with program managers.
• Develop and release controlled work instructions for Final Release.
• Identify improvement opportunities in Final Release processes.
• Collaborate with area stakeholders to resolve issues and maintain teamwork.
• Perform other duties as assigned by Manager and Director.

Skills

Medical Device Manufacturing

Final Release

Document Control

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 first shift role with the hours of Monday through Friday 7am - 3:30pm.

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 Medical 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-$31.