Inventory Management Specialist

Inventory Management Specialist cGMP — 21 CFR Part 111 / 21 CFR Part 117 / 21 CFR Part 507

Department:

Operations / Warehouse / Quality Reports to: Warehouse Manager (dotted line to Quality Assurance)

FLSA Status:

Non-exempt (adjust as needed)

Location:

[Facility location] Position Summary The Inventory Management Specialist is responsible for the receipt, identification, status control, storage, movement, traceability, and recordkeeping of all components, packaging, labels, in-process materials, finished goods, and — where applicable — animal food, animal food ingredients, and human food distributed, in accordance with the FDA's Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 111 (Dietary Supplements), 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), and 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals). This role ensures that every unit of inventory entering, residing in, or leaving the facility is uniquely identified, properly logged, traceable forward and backward by lot, segregated from incompatible materials — including segregation of human food from animal food and human food by-products intended for animal use — and supported by complete, contemporaneous, legible, and retrievable records suitable for FDA and third party inspections. Essential Duties and Responsibilities1. Receiving, Identification, and Lot Control Receive incoming components, dietary ingredients, packaging, labels, raw food materials, and animal food ingredients; visually examine each immediate container or grouping of containers — including shipping containers (totes, drums, tubs) and bulk vehicles — upon receipt for damage, broken seals, contamination, or deterioration. Verify each shipment against the supplier's invoice, guarantee, purchase order, and Certificate of Analysis (CoA). Assign and apply a unique identifier (lot, batch, or control number) to each unique lot within each unique shipment so it can be traced to the supplier, the date received, the name/identity of the material, and its current status — quarantined, approved, or rejected — and forward to the finished dietary supplement, food product, or animal food distributed. Ensure all animal food, raw materials, other ingredients, and rework are accurately identified. Place all human dietary supplement ingredients and packaging received into "On Hold" or "Quarantine" (Quarantine if damaged or visibly contaminated) immediately upon receipt and physically/electronically segregate them until Quality Control review and release. 2. Status Control and Material Disposition Maintain clear, unambiguous status labeling and system flags for all inventory: Quarantine, Approved/Released, Rejected, On Hold, Returned, and Reserve Sample . Move material between status states only on the documented authorization of Quality Control personnel. Identify, segregate, and physically control rejected components, packaging, labels, and products under a quarantine system to prevent their use until properly disposed of. Manage and maintain reserve samples of components and finished dietary supplements per established procedures. 3. Storage, Warehousing, and Distribution Controls Store all components, packaging, labels, in-process materials, finished products, and animal food under conditions that protect against contamination, mix-ups, deterioration, and allergen cross-contact , and prevent biological, chemical (including radiological), and physical contamination. Ensure containers used to hold animal food before distribution are designed, constructed of appropriate material, cleaned as necessary, and maintained to protect against contamination. Enforce FEFO (First Expired, First Out) and FIFO (First In, First Out) rotation; monitor and act on expiration dates, retest dates, and shelf-life limits. Maintain proper allergen segregation, designated storage zones, temperature-controlled areas, chemical/non-food separation, and — where applicable — strict segregation between human food, animal food, and unpackaged or bulk animal food to prevent cross-contamination, in accordance with the facility's Food Safety Plan and applicable cGMP requirements. For human food by-products held and distributed for use as animal food, ensure they are accurately identified during holding, held in containers/equipment that protect against contamination — including from trash and cleaning chemicals — labeled with the common or usual name when distributed, and shipped in containers/vehicles examined prior to use. 4. Inventory Logging, Traceability, and Recordkeeping Create and maintain complete, accurate, indelible, legible, contemporaneous, and attributable inventory records — created at the time the activity is performed — including the date, the identity of the product, the lot code, the quantity and unit of measure, and the signature or initials of the person performing the activity. Maintain receiving records, including CoAs, supplier invoices, supplier guarantees, visual examination results, documents necessary to establish supplier vendor approval participation and any relevant post received test results. Relevant documentation of material movement, status change, material review, and disposition decision — release, reject, rework, destruction, return-to-supplier — with date, time, lot, quantity, and signatures. Maintain forward and backward lot traceability linking: supplier lot → received lot → quarantine/release → staged batch → Batch Production Record (BPR) → finished lot → shipped lot → customer/consignee, so that any lot — human food, dietary supplement, or animal food — can be traced and contained within hours to support the facility's Recall Plan. Retain all records at the facility pursuant to the Company's Document Retention Policy and ensure offsite or electronic records are retrievable onsite within 24 hours of an FDA request. Follow Good Documentation Practices (GDP): no pencil entries, no overwrites, single line-through with initial and date for any correction, no backdating, and no use of "ditto" marks for cGMP entries. Use only validated electronic inventory/WMS/ERP systems with controlled access and audit trails consistent with 21 CFR Part 11 when records are maintained electronically. 5. Cycle Counts, Reconciliation, and Inventory Accuracy Perform daily, weekly, and periodic cycle counts; reconcile physical inventory to system inventory by lot and status. Investigate and document inventory discrepancies, variances, mis-picks, and shrinkage; escalate to Quality and Operations leadership and ensure all adjustments are approved and recorded. Reconcile components and labels issued to production against quantities consumed and returned, supporting the BPR's material reconciliation requirements. 6. Recall Readiness, Holds, and Returns Execute Quality-initiated holds, market withdrawals, and recalls quickly and accurately by pulling lot-level traceability data within the timelines required by SOP. Participate in mock recall drills and provide affected SKUs, lots, quantities on hand, locations, customers, and shipment dates from inventory records. Receive, segregate, identify, and log returned dietary supplements, human food, and animal food , and route them for material review and disposition by Quality Control. 7. Sanitation, Pest Control, and Facility Discipline Maintain warehouse and storage areas in a clean, orderly, pest-free condition; report and document any pest sightings, leaks, condensation, broken pallets, or damaged product immediately. Follow personal hygiene, GMP attire, and traffic-flow requirements when entering production or storage areas. 8. Continuous Improvement, Audits, and Training Support internal audits, supplier audits, customer audits, and FDA inspections by retrieving requested records — receiving logs, lot histories, status changes, COAs, BPR linkages — on demand. Identify and recommend improvements to inventory SOPs, labeling, layout, and WMS/ERP configuration to strengthen cGMP compliance and operational efficiency. Complete and maintain documentation of all required cGMP, food safety, animal food safety, allergen, hygiene, Good Documentation Practices (GDP), and Part 111 training, including training in the principles of animal food hygiene and animal food safety where applicable. Required Qualifications High school diploma or GED required; Associate's or Bachelor's degree in Supply Chain, Logistics, Food Science, or a related field preferred. Ability to adapt to inventory, warehouse, or materials management experience in an FDA-regulated environment — dietary supplement, human food, animal food / pet food / livestock feed, beverage, nutraceutical, cosmetic, or pharmaceutical. Working knowledge of 21 CFR Part 111, 21 CFR Part 117, and 21 CFR Part 507 cGMP requirements, third party audit requirements and other relevant standards, particularly receiving, identification, quarantine/release, lot traceability, warehousing, holding and distribution, and recordkeeping. Hands-on experience with

WMS / ERP

systems — SAP, Oracle, NetSuite, Microsoft Dynamics, or comparable — and barcode/scanner-based inventory transactions. Demonstrated ability to apply Good Documentation Practices (GDP) and to produce contemporaneous, legible, attributable records. Strong attention to detail, math/reconciliation skills, and the ability to identify and escalate discrepancies. Ability to read, write, and communicate effectively in English; additional languages a plus. Preferred Qualifications Experience supporting FDA inspections, third-party GMP audits —

NSF, UL, NPA, SQF, BRCGS

— or organic/non-GMO certifications. Familiarity with 21 CFR Part 11 electronic records/electronic signatures requirements. Experience with allergen control programs, FSMA Preventive Controls, the

FSMA 204

Food Traceability Rule — Critical Tracking Events and Key Data Elements — and recall execution. PCQI — Preventive Controls Qualified Individual for Human Food — and/or PCQI-Animal Food training, or HACCP certification. Experience handling animal food, pet food, livestock feed, or human food by-products distributed for use as animal food under 21 CFR Part 507. Physical Requirements and Work Environment Ability to stand, walk, bend, reach, and climb for extended periods. Ability to lift up to 25 lbs unassisted and to safely move heavier loads with mechanical assistance. Ability to work in temperature-controlled storage areas — ambient, refrigerated, and/or frozen as applicable. Ability to wear required

PPE:

safety shoes, hairnets, beard nets, gloves, smocks/lab coats, hearing protection, and high-visibility vests as required. Availability for shift work, weekends, overtime, and physical inventories as business needs require. Key Performance Indicators (KPIs) Inventory accuracy by lot and status — target ≥ 99.5%. Receiving cycle time and on-time put-away. Quarantine release cycle time. Documentation error rate / GDP findings per audit. Recall / mock recall response time — target: full lot trace within 2-4 hours. Zero critical or major findings related to inventory in FDA, customer, or third-party audits. Expired / obsolete inventory as a % of total on-hand value. Compliance Statement This position is governed by the FDA's cGMP regulations at 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements), 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), and 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals), as well as all applicable company SOPs, the facility's Food Safety Plan(s), and customer/regulatory commitments. Failure to follow cGMP requirements, falsification of records, or unauthorized movement of quarantined or rejected material may result in disciplinary action up to and including termination. This job description is intended to convey information essential to understanding the scope of the position; it is not an exhaustive list of skills, duties, or responsibilities. Duties may be modified at the discretion of management.

Pay:

From $20.00 per hour

Work Location:

In person