Manages the activities of the Incoming Quality Control (IQA) department to ensure incoming raw materials, components and contract manufactured products meet their approved specifications or other regulatory requirements. Supervises IQA Operators.

• Ensures that IQA Operators conduct inspections according to approved procedures/specifications.
• Audits inspection documentation for compliance and makes the final disposition for the materials.
• Schedules and supervises IQA Operator activities.
• Directs the training for IQA Operators.
• Supervises and coordinates Yearly Inspection of Retain Samples on a monthly basis.
• Tracks the status of incoming materials, ensures computer databases/worksheets are updated and keeps QA Manager and other appropriate departments informed of inspection status.
• Reviews/revises department standard operating procedures (SOP) and master specifications for accuracy and conformance with regulatory/vendor/compendia/other requirements.
• Conducts quality investigations for IQA related deviations and nonconformances and recommends corrective action / preventative action (CAPA) plan.
• Coordinates documentation with Procurement and QA Management for SCAR (Supplier Corrective Action Reports) to be sent to suppliers for non-conforming incoming materials and components
• Coordinates Vendor Quarterly Report cards with input from numerous departments, prepares reports for Procurement.
• Maintains and manages Safety Data Sheets (SDS), including updating, organizing, and distributing SDS documentation in accordance with regulatory requirements.
• May participate in FDA inspections and third-party audits as required.
• Provides backup for data entry into the inventory management system.
• Provides QA staff assistance with receiver packet review for Annual Product Review reports on a monthly basis.
• Assists or directs staff to assist with customer complaint inspections as needed.
• All other duties as assigned.

Requirements

• Requires exceptional knowledge of Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) regulations and U.S. Pharmacopoeia/National Formulary (USP/NF). Must be familiar with American National Standard Institute (ANSI) Z1.4 or equivalent sampling plans.
• High degree of proficiency with verbal and written communication skills and effective multi-tasking skills. Must possess a proficient working knowledge of Microsoft Office suite, including knowledge of word processing, spreadsheet and database applications. Must be self-motivated; organized; detail oriented/accurate; able to work independently to resolve problems.
• Proficiency in advanced mathematical techniques and experience with analytical balances and hand-held measuring devices such as calipers. To backup department, should be able to lift up to 50 pounds and be able to use a pallet jack, a drum dolly and a drum roller. Sampling activities may require standing for prolonged periods of time.
• Requires a Bachelor of Science degree in a scientific discipline OR a minimum of 5 years pharmaceutical/FDA-regulated experience, ideally in a Quality Control/ Quality Assurance capacity. Previous supervisory experience preferred.

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