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Millstone Medical Outsourcing is looking for an energetic individual to join its Operations team. Millstone is a fast growing, fast paced medical service provider for the top companies in the industry.
Position Summary
At Millstone Medical, the Production Associate II is responsible for performing manufacturing, assembly, inspection, and packaging activities associated with aseptic and non-aseptic medical device production. This role ensures products are manufactured in accordance with approved procedures, applicable cGMP and medical device quality system requirements, and established safety and quality standards.
The Production Associate II performs routine and complex production activities, including equipment setup and operation, component preparation, product assembly, filling, inspection, packaging, and in-process testing. The role requires strong attention to detail, adherence to written procedures, accurate documentation, and the ability to work effectively in controlled manufacturing environments.
The Production Associate II may also assist with troubleshooting, investigations, process improvements, equipment activities, and training of less-experienced associates.
Essential Duties and Responsibilities
- Perform aseptic and non-aseptic medical device manufacturing operations in accordance with approved batch records, SOPs, work instructions, and manufacturing procedures.
- Perform medical device assembly, processing, inspection, labeling, and packaging activities.
- Perform vial and syringe-related manufacturing activities, including filling, stoppering, capping, assembly, inspection, and packaging, as applicable.
- Set up, operate, clean, and maintain production equipment and manufacturing areas.
- Execute aseptic processing activities using proper gowning, cleanroom behavior, and aseptic technique.
- Perform line clearance, equipment clearance, and area readiness activities before and during manufacturing operations.
- Conduct and document in-process inspections and quality checks, including component verification, visual inspection, assembly verification, fill-volume checks, and other required testing.
- Accurately complete batch records, Device History Records (DHRs), logbooks, electronic records, forms, and other required manufacturing documentation in accordance with Good Documentation Practices (GDP).
- Follow applicable cGMP, GDP, FDA, ISO, medical device quality system, safety, and environmental requirements.
- Identify and promptly report deviations, nonconformances, equipment issues, process abnormalities, or potential product quality concerns.
- Assist with deviation investigations, nonconformance investigations, CAPA activities, and other quality-related investigations as assigned.
- Support equipment troubleshooting and communicate issues to Maintenance, Engineering, Quality, or other appropriate departments.
- Perform material and component staging, verification, reconciliation, and movement in accordance with established procedures.
- Maintain production areas in a clean, organized, and compliant condition.
- Follow procedures for proper material identification, traceability, handling, and disposition.
- Participate in continuous improvement initiatives focused on safety, quality, productivity, and process efficiency.
- Provide training and guidance to Production Associates when qualified to do so.
- Work collaboratively with Quality Assurance, Quality Control, Engineering, Maintenance, Warehouse, and other cross-functional teams.
- Support new product introductions, process changes, equipment qualifications, and validation activities as assigned.
- Perform other duties as assigned by Production or Manufacturing leadership.
Quality & Compliance Responsibilities
- Follow all applicable cGMP, GDP, FDA, ISO 13485, and company quality system requirements.
- Maintain accurate and complete documentation to ensure product and component traceability.
- Ensure manufacturing activities are performed in accordance with approved procedures, specifications, and validated processes.
- Follow established procedures for handling deviations, nonconforming product, and process discrepancies.
- Immediately communicate quality concerns or potential product impact to appropriate personnel.
- Participate in audits, inspections, and quality initiatives as required.
- Maintain a strong quality mindset and ensure products are manufactured according to established requirements.
Qualifications
- High school diploma and/or 4-year degree required.
- 2+ years of experience in pharmaceutical, biotechnology, medical devices, or other regulated manufacturing environments preferred.
- Experience with aseptic processing, medical device assembly, cleanroom manufacturing, vial/syringe production, or related manufacturing processes preferred.
- Working knowledge of cGMP, GDP, aseptic processing principles, and medical device quality requirements.
- Familiarity with ISO 13485 and FDA Quality System requirements preferred.
- Ability to read and follow SOPs, batch records, DHRs, work instructions, drawings, and technical documentation.
- Strong attention to detail and ability to accurately document manufacturing activities.
- Ability to identify and communicate process or quality issues promptly.
- Ability to work independently while also functioning effectively as part of a team.
- Ability to work in controlled manufacturing and cleanroom environments while wearing required PPE and gowning.
- Ability to work flexible shifts, weekends, overtime, or extended hours as required by production schedules.
Physical Requirements
- Ability to stand and walk for extended periods during manufacturing operations.
- Ability to perform repetitive hand and arm movements.
- Ability to perform fine-motor tasks and detailed assembly activities.
- Ability to perform detailed visual inspections of medical devices, components, vials, syringes, and packaging.
- Ability to lift, carry, push, and pull materials and equipment within established safety limits.
- Ability to work in cleanroom environments with required gowning and PPE.
- Ability to maintain situational awareness while working around manufacturing equipment.
Key Competencies
- Aseptic & Non-Aseptic Manufacturing
- Medical Device Production & Assembly
- Vial & Syringe Manufacturing
- cGMP & Quality System Compliance
- Cleanroom Operations
- Equipment Setup & Operation
- Documentation & Data Integrity
- Attention to Detail
- Quality Mindset
- Problem Solving
- Communication
- Teamwork
- Accountability
- Continuous Improvement
For Additional Information:
Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay and voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing’s opportunities, visit us online at www.millstonemedical.com. If interested, please forward resume to this posting or apply in person at 580 Commerce Drive, Fall River, MA 02720.
#IND132
Job Type: Full-time
Pay: $28.00 - $32.00 per hour
Experience:
- Manufacturing: 1 year (Required)
- syringe or vial filling: 1 year (Preferred)
Work Location: In person
