Assembler ; 1st shift

Job Description

Responsible for performing assembly, packaging, and labeling of medical products with a higher level of proficiency, in compliance with GMP requirements, BD procedures, and quality standards. This role operates manufacturing equipment across multiple processes, ensures product quality, and supports manufacturing operations by troubleshooting issues, assisting in process execution, and promoting adherence to safety and operational standards. Additionally, this position provides support to other areas and helps reinforce process awareness among associates.

• Perform assembly, packaging, and labeling of medical devices and pharmaceutical products (e.g., Surgical, Vascular) in compliance with GMP, SOPs, and quality standards.
• Operate and be certified in multiple manufacturing processes or groups of operations across different areas.
• Execute production activities using batch records, job aids, SOPs, and product specifications.
• Interpret manufacturing documentation to ensure accurate and efficient process execution.
• Perform in-process and final visual inspections to ensure product and packaging meet quality requirements.
• Accurately complete and review batch records, production logs, and documentation in compliance with GMP, GDP, FDA, and ISO standards.
• Meet daily production targets in alignment with the established day-by-hour production plan.
• Monitor, capture, and report downtime, scrap, and production performance metrics.
• Coordinate execution of manufacturing schedules for assigned batches or operations.
• Ensure availability of required materials before initiating operations.
• Handle, segregate, and dispose of non-conforming materials in accordance with established procedures.
• Maintain cleanliness and organization of work areas, equipment, and operations in alignment with 5S and cleanroom standards.
• Support manufacturing-related activities including calibration, work orders, and validation processes as required.
• Identify, troubleshoot, and communicate production issues, risks, or deviations to the supervisor or designee in a timely manner.
• Support and maintain a safe work environment, including participation in safety programs such as Employee Safety Observations (ESO).
• Follow all safety requirements and properly use personal protective equipment (PPE), including but not limited to lab coats, gloves, hair/beard covers, shoe covers, hearing protection, eye protection, and specialized cleanroom garments as required.
• Provide guidance, training, and knowledge sharing to other associates as needed.
• Support continuous improvement initiatives, including 5S, standardization, and process simplification.
• Provide backup support across multiple equipment, operations, or areas as required.
• Communicate issues, concerns, and potential risks that may impact product quality or manufacturing processes.
• Comply with all company policies and regulatory requirements.
• Perform other duties as assigned.

• Education:
  
  Completed High School or equivalent preferred.
• Experience:
  
  1 to 3 years of experience in a high paced medical manufacturing environment.

• Professional Skills Knowledge of EH&S standards and safety procedures (required).
• Strong understanding of manufacturing processes and production flow (required).
• Knowledge of GMP and Quality Systems; familiarity with GDP is required.
• Ability to interpret and apply manufacturing documentation (e.g., SOPs, batch records, specifications).
• Ability to perform inspections and testing activities (visual, in-process, and final product verification).
• Intermediate troubleshooting and problem-solving skills related to equipment, processes, and set-up conditions.
• Basic understanding of equipment maintenance principles.
• Awareness of escalation processes for quality, safety, or production issues.
• Basic mathematical skills (addition, subtraction, multiplication, division, fractions, decimals, and percentages).
• Basic computer skills, including proficiency in a Windows environment and Microsoft Office (Outlook, Word, Excel).
• Effective oral and written communication skills; bilingual Spanish/English preferred.
• Ability to work independently and within…