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July 14, 2022

| Tags: career, hiring, jobs, production

1. Job purpose

The Production Support Specialist will be responsible for providing critical support functions to medical device product manufacture and product development. Important job functions include circulating for processing rooms, inventory management of processing room supplies, light setup and cleanup for processing events as well as equipment preventive maintenance.

2. Duties and responsibilities

  • Production Circulation and Support
  • Available during production events to provide extra supplies or additional hands-on support including packaging and shipping
  • Act as an operational link between or after shift changeover
  • Assist manufacturing and inventory staff with manufacture and packaging of marketing samples.
  • Inventory Management for Cleanroom Supplies
  • Follow work instructions to create subassemblies required for medical device production such as reagents and sterile and non-sterile production trays
  • Maintain stock of required PPE and raw materials in the cleanroom
  • Work with Inventory Specialist to ensure stock rotation and timely procurement
  • Production Set-up/Tear Down
    • Setup cleanroom for production events: Equipment, reagents, packaging supplies
    • Breakdown of equipment after production events: Cleaning equipment, restoring room to resting state
    • Cleaning of cleanroom and gowning room following formal procedures for daily, weekly, monthly and quarterly cleaning
  • Equipment support
    • Performs routine maintenance and daily checks on production and QC equipment
    • Performs in-house calibration
  • Participate in production and quality planning meetings as needed.
  • May interact with external customer contacts such as
    • Participating in tours for visitors including VIPs
    • May be questioned and/or observed during audits.
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO and FDA regulations.

3. Qualifications

  • 2-3 years of manufacturing support experience in the medical device industry
  • Experience working in cleanrooms and/or regulated environment
  • 2-3 years experience working with ERP systems preferred (ie: NetSuite, SAP)
  • Broad experience with quality systems (ISO 13485) including but not limited to: Good Documentation Practices, Non-conformances & CAPA investigations as well as good manufacturing practices.
  • Strong communication skills and willingness to work as part of a team

4. Working conditions

  • 40 hours a week with additional hours as required by production schedule
  • Office, cleanroom and laboratory setting

5. Physical requirements

  • Ability to stand for prolonged periods of time
  • Ability to lift up to 75lbs
  • No special physical requirements

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Norfolk, VA 23508: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • manufacturing support: 2 years (Preferred)

Work Location: One location

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