We are seeking a detail-oriented Raw Material Quality Specialist to join a leading manufacturer of topical animal health and wellness products. This role is responsible for overseeing the full lifecycle of incoming raw materialsfrom initial receipt and inspection to testing and final release. You will play a critical role in ensuring that all materials used in production meet USP FDA and internal quality standards collaborating closely with procurement and manufacturing teams to maintain a compliant and efficient supply chain.
Primary Responsibilities
Inspection & Sampling: Perform visual inspections of incoming materials for damage or contamination; collect representative samples for testing following SOPs and regulatory guidelines.
Testing & Release: Execute identity tests interpret results against USP or internal specifications and manage the quarantine/release process to ensure production timelines are met.
Documentation: Maintain precise records for all receipts COAs and test results. Investigate non-conforming materials and support regulatory audits.
Vendor Qualification: Evaluate new vendors and materials based on quality history and risk; assist in the creation and approval of raw material specifications.
Compliance: Ensure strict adherence to GMP GLP and safety procedures during all material handling activities.
Qualifications
Education: Bachelors Degree in Chemistry Biology Pharmaceutical Sciences or a related scientific field.
Experience: 5 years of experience in raw material receiving and qualification within a regulated environment (Pharmaceutical Biotech or Cosmetics).
Technical Knowledge: Strong working knowledge of USP/NF standards FDA regulations and GMP/GLP requirements.
Systems: Proficiency in ERP/Inventory systems (e.g. SAP Oracle) and Microsoft Office Suite (Excel Word Outlook).
Skills: Ability to read and interpret technical documents (SOPs Batch records) and make sound quality judgments independently.
Physical Requirements & Work Environment
Shift Flexibility: Ability to work on-site with flexibility for evenings weekends or overtime as production demands require.
Physical Activity: Continual standing/walking; ability to bend stoop reach overhead and occasionally lift up to 50 lbs.
Environment: Must be comfortable working in temperature-controlled environments (cold rooms or warm production areas) and wearing full PPE (masks gowns gloves etc.).
Sensory: Specific vision abilities (color depth and focus) are required for material inspection and testing.
Quality Control: Raw Material Inspection Sampling Protocols Identity Testing COA (Certificate of Analysis) Review Quarantine Management Specification Development.
Quality Assurance: Document Control SOP (Standard Operating Procedure) Writing Change Control Vendor Qualification Audit Preparation Non-Conformance Investigation (NCMR).
Laboratory & Technical: Analytical Testing Batch Record Review Technical Documentation Material Traceability Safety Data Sheets (SDS).
Software: ERP Systems (SAP Oracle or Microsoft Dynamics) Inventory Management Software Advanced Excel (VLOOKUP/Pivot Tables) Microsoft Office Suite.
Required Skills:
Technical & Industry Skills Regulatory Compliance: cGMP GLP FDA Regulations USP/NF Standards OSHA Safety Standards. Quality Control: Raw Material Inspection Sampling Protocols Identity Testing COA (Certificate of Analysis) Review Quarantine Management Specification Development. Quality Assurance: Document Control SOP (Standard Operating Procedure) Writing Change Control Vendor Qualification Audit Preparation Non-Conformance Investigation (NCMR). Laboratory & Technical: Analytical Testing Batch Record Review Technical Documentation Material Traceability Safety Data Sheets (SDS). Software: ERP Systems (SAP Oracle or Microsoft Dynamics) Inventory Management Software Advanced Excel (VLOOKUP/Pivot Tables) Microsoft Office Suite.
We are seeking a detail-oriented Raw Material Quality Specialist to join a leading manufacturer of topical animal health and wellness products. This role is responsible for overseeing the full lifecycle of incoming raw materialsfrom initial receipt and inspection to testing and final release. You wi...
We are seeking a detail-oriented Raw Material Quality Specialist to join a leading manufacturer of topical animal health and wellness products. This role is responsible for overseeing the full lifecycle of incoming raw materialsfrom initial receipt and inspection to testing and final release. You will play a critical role in ensuring that all materials used in production meet USP FDA and internal quality standards collaborating closely with procurement and manufacturing teams to maintain a compliant and efficient supply chain.
Primary Responsibilities
Inspection & Sampling: Perform visual inspections of incoming materials for damage or contamination; collect representative samples for testing following SOPs and regulatory guidelines.
Testing & Release: Execute identity tests interpret results against USP or internal specifications and manage the quarantine/release process to ensure production timelines are met.
Documentation: Maintain precise records for all receipts COAs and test results. Investigate non-conforming materials and support regulatory audits.
Vendor Qualification: Evaluate new vendors and materials based on quality history and risk; assist in the creation and approval of raw material specifications.
Compliance: Ensure strict adherence to GMP GLP and safety procedures during all material handling activities.
Qualifications
Education: Bachelors Degree in Chemistry Biology Pharmaceutical Sciences or a related scientific field.
Experience: 5 years of experience in raw material receiving and qualification within a regulated environment (Pharmaceutical Biotech or Cosmetics).
Technical Knowledge: Strong working knowledge of USP/NF standards FDA regulations and GMP/GLP requirements.
Systems: Proficiency in ERP/Inventory systems (e.g. SAP Oracle) and Microsoft Office Suite (Excel Word Outlook).
Skills: Ability to read and interpret technical documents (SOPs Batch records) and make sound quality judgments independently.
Physical Requirements & Work Environment
Shift Flexibility: Ability to work on-site with flexibility for evenings weekends or overtime as production demands require.
Physical Activity: Continual standing/walking; ability to bend stoop reach overhead and occasionally lift up to 50 lbs.
Environment: Must be comfortable working in temperature-controlled environments (cold rooms or warm production areas) and wearing full PPE (masks gowns gloves etc.).
Sensory: Specific vision abilities (color depth and focus) are required for material inspection and testing.
Quality Control: Raw Material Inspection Sampling Protocols Identity Testing COA (Certificate of Analysis) Review Quarantine Management Specification Development.
Quality Assurance: Document Control SOP (Standard Operating Procedure) Writing Change Control Vendor Qualification Audit Preparation Non-Conformance Investigation (NCMR).
Laboratory & Technical: Analytical Testing Batch Record Review Technical Documentation Material Traceability Safety Data Sheets (SDS).
Software: ERP Systems (SAP Oracle or Microsoft Dynamics) Inventory Management Software Advanced Excel (VLOOKUP/Pivot Tables) Microsoft Office Suite.
Required Skills:
Technical & Industry Skills Regulatory Compliance: cGMP GLP FDA Regulations USP/NF Standards OSHA Safety Standards. Quality Control: Raw Material Inspection Sampling Protocols Identity Testing COA (Certificate of Analysis) Review Quarantine Management Specification Development. Quality Assurance: Document Control SOP (Standard Operating Procedure) Writing Change Control Vendor Qualification Audit Preparation Non-Conformance Investigation (NCMR). Laboratory & Technical: Analytical Testing Batch Record Review Technical Documentation Material Traceability Safety Data Sheets (SDS). Software: ERP Systems (SAP Oracle or Microsoft Dynamics) Inventory Management Software Advanced Excel (VLOOKUP/Pivot Tables) Microsoft Office Suite.