Specification Specialist

Creative Werks•Elk Grove Village, IL

21h•Onsite

About The Position

The Specification Specialist owns the creation, maintenance, and control of product specifications for co-manufactured and co-packed food products and, where applicable, OTC drug products. This role partners with Quality, Production, Maintenance, Regulatory, Client Services, and clients to ensure specifications are accurate, approved, and aligned to client requirements, food product specifications, food safety plans, applicable regulatory compliance, OTC drug quality/GMP and labeling requirements, and plant capabilities. The position is key to consistent product quality by driving specification governance, change control, and data integrity across internal systems and client portals for both food and OTC drug products.

Requirements

Working knowledge of SQF/BRCGS or comparable GFSI schemes, GMPs, HACCP/Preventive Controls, allergens, and food labeling fundamentals; working knowledge of OTC drug GMP and labeling fundamentals (as applicable to the site/client requirements) is preferred.
Strong attention to detail and document control discipline with ability to manage multiple specification records, change controls, and deadlines.
Proficient in Microsoft Office (Excel, Word, Outlook) and comfortable working in ERP/QMS systems and customer portals for food specification and OTC drug specification management.
Ability to read and write English fluently.
Strong interpersonal and communication skills with proven ability to collaborate effectively with internal teams and external clients on food and OTC drug specification requirements
Bachelor’s degree in Food Science, Chemistry, Biology, Nutrition, or related field; or equivalent combination of education and experience.
2–5 years of experience in food manufacturing quality/regulatory/specifications (finished goods and packaging specifications), ideally within co-manufacturing/co-packing; experience supporting OTC drug products (product specifications, packaging/label requirements, and controlled documentation) is a strong plus
Attend all required food safety training sessions (GMP, SQF, HACCP/Preventive Controls, allergen, food defense, etc.) and required training supporting OTC drug products (OTC drug GMP/quality system and labeling requirements).
Ensure product specifications accurately reflect required controls and requirements for food products (food safety controls, allergens, client/regulatory requirements) and for OTC drug products (defined quality attributes, required testing/COA elements, labeling requirements, and controlled documentation expectations), and that specifications are maintained as controlled documents.
Support investigations and corrective actions related to specification deviations, out-of-specification results, and client complaints for food and OTC drug products.
Promote and enforce company rules regarding food safety, product integrity, and data accuracy for specification records, including expectations for controlled food specification records and controlled OTC drug specification records.
Participate in company GMP walks

Nice To Haves

working knowledge of OTC drug GMP and labeling fundamentals (as applicable to the site/client requirements) is preferred.
experience supporting OTC drug products (product specifications, packaging/label requirements, and controlled documentation) is a strong plus

Responsibilities

Create, revise, and maintain product specifications for food products and OTC drug products, including defined specification fields such as: formulation/processing targets, critical quality attributes, sensory standards, microbiological criteria, allergens, net weight/MAV, storage/handling, shelf life, packaging components, label text requirements, coding/traceability requirements, pallet patterns, and sampling/testing requirements.
Coordinate cross-functional review and approval of food product specifications and OTC drug product specifications (Quality, Production, Maintenance, Regulatory, Client Services, and clients), ensuring approvals are documented and controlled, and that updates/deviations are reviewed, authorized, and communicated prior to execution.
Manage specification change controls and deviations for food and OTC drug products: assess impacts to product specifications (including allergens, labeling, QC inspections, microbiological requirements, artwork, sampling plans, and production/line capability); document risk/impact; communicate changes to affected departments; and obtain required internal and client approvals before implementation.
Ensure product specifications reflect food safety and food quality requirements (HACCP/Preventive Controls, preventive control parameters, allergens, microbiological criteria, foreign material controls, net weight/MAV, and sensory standards) and, where applicable, ensure OTC drug product specifications reflect defined quality attributes and compliance requirements (e.g., identity/strength/purity criteria, required testing/COA elements, and controlled documentation expectations).
Maintain product specification master data for food and OTC drug products in internal systems (SharePoint and ERP) and shared folders; ensure data integrity (required fields completed, current approved versions posted, effective dates captured), and maintain audit-ready records that support customer, regulatory, and third-party audits.
Review and verify label and packaging requirements for finished goods, including food labeling (ingredient statement, allergen statements, Nutrition Facts, claims, coding requirements) and OTC drug labeling (Drug Facts panel, active ingredient(s) and strength, indications/uses, warnings, directions, inactive ingredients, and required statements), utilizing the client and Regulatory team as needed.
Define and maintain finished good testing requirements and sampling plans aligned to food product specifications, client requirements, and OTC drug product specifications (COA requirements/verification, sensory, microbiological testing, and any required product attribute verification); coordinate with QC for execution, documentation, and record retention.
Support new item onboarding and commercialization for food and OTC drug products by collecting client specification requirements, building initial product specifications, ensuring packaging/label content is verified, and confirming readiness for trials and/or first production (line capability, inspection criteria, and release requirements).
Investigate and resolve specification-related issues (client complaints, out-of-specification results, deviations) by identifying gaps in food product specifications and/or OTC drug product specifications, updating specification content and acceptance criteria, and supporting corrective actions and preventive actions as needed.
Maintain organized, current specification documentation used by day-to-day operations for food and OTC drug finished goods, ensuring all controlled specifications, approvals, and change records are audit-ready for client audits, regulatory inspections, and third-party audits (e.g., SQF).
Provide timely responses to client requests and ensure clear internal communication when food specifications and/or OTC drug specifications change.
Perform other duties as assigned by Management