Documentation Specialist

Piping Rock • Farmingdale, NY

6d

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.
• Bachelor’s in science preferred. 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.
• Must be organized and able to keep records.
• Must be able to lift 50lbs.
• Must be able to sit or stand for 8 hours.
• Ability to work in a physically challenging environment, including bending, twisting, and standing for up to 8 hours
• Work environment - may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish, and shellfish)
• We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines.

Nice To Haves

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED