Quality Assurance Release Coordinator

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Regular Full-Time Oak Brook, IL, US

Salary Range: $62,500.00 To $66,000.00 Annually

The Coordinator is responsible for performing duties and assisting the Manager, Quality Assurance with product disposition functions, encompassing the review of production batch records and the associated documentation required to release a production lot. He/she ensures compliance to product specification, good documentation practices, data entry, completeness of COAs, Company SOPs and cGMPs reviewing all documents from Production, Quality Control Laboratory, Quality Assurance and/or other related documents to a batch.

The completed production batch (finished product) does not release from the building without the incumbent’s approval to prevent distribution of non-conforming products to customers. A similar release process is followed with the review of the raw materials sampling, testing, approve and/or reject activities.

• Coordinates the assembly of batch information generated by Quality Assurance, Production, Manufacturing and Quality Control Departments.
• Reviews and audits batch records. Collects data for trending performance measurements.
• Makes final decision on product release, in absence of discrepancies.
• Coordinate correction of documentation errors with appropriate department(s); and notifies management of batch record errors.
• Notifies management of discrepancies and documentation errors with batch records.
• Verifies counts of finished products prior to release. Notifies production of count discrepancies.
• Prepares release or quarantine notices/stickers for in-process batches and finished products.
• Maintains the quarantine hold area.
• Performs transactions in Adage system.
• Troubleshoots quality issues and initiates non-conformance investigations and deviations, as needed.
• Collects information for investigations of quality issues.
• Maintains the deviation files and deviation log.
• Maintains all in process batch files. Archives all completed batch records.
• Provides customers with Certificates of Compliance and Certificates of Analysis when necessary.
• Proficient at reading, reviewing, and auditing documents and follow procedures.
• Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
• Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances etc.)

ADDITIONAL RESPONSIBILITIES

• Participates in cGMP compliance audits and other committees, as required by the Manager, Quality Assurance.
• Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance (e.g. serves as back-up to Inspector, Quality Assurance and Inspector, Receipt).
• Supports the Winner’s Circle and Blistex Quality processes.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• High School Diploma or GED with 4-6 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
• Bachelor's degree in Chemistry, Biology, or related scientific discipline with 2-3 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
• Must demonstrate effective communication skills for interactions with Quality colleagues, and colleagues from numerous functional areas.
• Must listen actively and readily assumes responsibility for actions. Capable of managing tactical steps to push tasks forward.
• Proficient at reading, reviewing, and auditing documents and follow procedures.
• Mastered the understating of Batch documentation requirements and all associated production and compliance steps.
• Proficient at understanding, reviewing, and auditing all compliance steps associated with the production of OTC drugs (i.e., line clearances, filling/packaging labeling, production sampling requirements, batch records, deviations, non-conformances…