Documentation Specialist- 7am-330pm

Piping RockFarmingdale, NY
$30 - $30Onsite

About The Position

This role supports production, R&D, and QA by ensuring the accuracy, control, and compliance of all quality-related documents such as batch records, controlled documents, training files, and audit-related documentation within the Quality Management System.

Requirements

  • Must comply with GMP requirements; specific functions will be discussed in GMP and on the job training.
  • High school diploma or equivalency required.
  • Strong computer knowledge with Microsoft Office is required.
  • Project Management skills are required.
  • Must have excellent verbal, written and interpersonal communication skills.
  • Must have excellent mathematical skills.
  • Must be organized and able to keep records.

Nice To Haves

  • Bachelor’s in science preferred.
  • Experience in R&D, QA or Production in the Dietary Supplement, Food or Pharmaceutical Industry is a plus.
  • Experience with FDA, GMP regulated industries a plus.

Responsibilities

  • Create and Issue batch production documentation in alignment with schedule requests.
  • Review and close production tickets upon completion.
  • Update the production schedule as needed to reflect workflow changes.
  • Collaborate with R&D on trial batches and ensure proper documentation.
  • Perform MBR (Master Batch Record) revisions and manage change control activities.
  • Updates formulas and master batch record instructions.
  • Maintain and revise SOPs and OPLs as required.
  • Distribute updated SOPs/OPLs to appropriate personnel and departments.
  • Maintain and update the training matrix for the QA department and other functions.
  • Issues required paperwork for new hire training and orientation.
  • Support internal audit activities, including collecting documents and preparing files.
  • File and archive controlled documentation in accordance with document retention policies.
  • Order and maintain office supplies for the QA department.
  • Provide general clerical and organizational support to ensure smooth QA operations.
  • Help maintain a professional and organized workspace.
  • Perform other tasks as needed.

Benefits

  • Medical
  • Dental
  • Vision
  • 401K with Company Match
  • Pet insurance
  • Fun and exciting company events
  • Summer Picnic
  • Festive Packages
  • Holiday Celebrations
  • Associate referral bonuses
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