Documentation Specialist- 7am-330pm

Job Description 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. 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 Master Batch Record revisions and manage change control activities. Update 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. Issue 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. Qualifications Compliance with GMP requirements (specific functions will be discussed in GMP and on the job training). Bachelor’s degree in science preferred; high school diploma or equivalency required. Strong computer knowledge, including Microsoft Office. Project Management skills required. Excellent verbal, written, and interpersonal communication skills. Strong mathematical skills. Organized and able to keep records. Experience in R&D, QA, or Production in the Dietary Supplement, Food, or Pharmaceutical Industry is a plus. Experience with FDA, GMP regulated industries is a plus. Physical Requirements Must be able to lift 50 lbs. Must be able to sit or stand for up to 8 hours. Ability to work in a physically challenging environment, including bending, twisting, and standing for up to 8 hours. Work environment may expose employees to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish, and shellfish). Work Hours Monday – Friday, 7:00 am – 3:30 pm Benefits Medical, Dental, Vision, 401(k) with company match, pet insurance, and more. Additional Requirements We are a drug‑free workplace, regulated by the FDA, and you must successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Equal Opportunity Statement Piping Rock Health Products, Inc. is an Equal Opportunity Employer. #J-18808-Ljbffr