Nolato is a global leader in precision injection molding and contract manufacturing for the world’s most successful healthcare, automotive, and industrial OEMs.

Join an organization that is respected throughout the industry for our advanced technology, quality, and innovation – all while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review Batch Records for compliance and accuracy, including;
  - Start-up/Adjustment Requests
  - Process Set-up Checklists
  - Attribute Tally Sheets
  - Label verification
  - SPC and/or Variable data (hard copy and/or electronic)
  - 5s press audits
  - Mold cleaning 
• Work with Area Managers to have any discrepancies corrected in a timely manner. 
• File completed Batch Records in a manner to permit recovery of documents for up to 15 years. 
• Issue a list of Hold Tickets and enter MRB dispositions for all Hold Tickets on a daily basis.
• Initiation and/or management of document changes in MQ1 in the form of Change Requests. Will be responsible to typing changes revised documents, listing document changes, notifying those responsible when approvals are late/overdue and distributing hard copies in Process Binders and Procedure Manuals after approval.
• Filing and maintenance of clean room monitoring records (particle counts) and trend analysis via EXCEL.
• Working with multiple departments such as Engineering, Process Engineering, and Quality, the DCS will help to create and maintain new/amended Process Binders containing Process Sheets, Mold Set-up sheets, QARs, Control Plans, etc. for all part number
• Participates in Customer Audits, ISO Audits and Internal Audits as needed to provide supporting documentation.
• Other related duties as assigned.

QUALIFICATIONS:

• Two year college degree or equivalent experience.
• Strong computer skills, particularly in the following:
• WORD™ (memos, instructions, document updates, etc.)
• EXCEL™ (spreadsheets, charting, data sorting, etc.)
• Must be able to type efficiently and accurately
• Strong organizational skills with emphasis on document accuracy.
• Must be self motivated and be able to work independently with minimal supervision.
• Prior QC and Document Control experience a plus.
• Prior experience in a FDA regulated industry a plus.