Specialist, Quality Assurance

WHERE YOU WILL WORK

Without compromising our steadfast commitment to Quality, Safety and Sustainability our manufacturing and packaging facility produces in excess of 70MM units per year. This is a demonstration of our can-do attitude, collaborative spirit, focus on innovation and continuous improvement mindset. Always People First! 

 

JOB SUMMARY

The Specialist, Quality Assurance, is responsible for the review and approval of Bills of Materials (BOMs) of Bulk and Finished Goods. This position oversees the release of both OTC and Non-OTC Finished Goods, and conducts thorough reviews of batch records, specifications, procedures, protocols, and related documentation to ensure compliance with Good Manufacturing Practices (GMP). Additional duties include supporting both internal and external GMP audits. The role encompasses a broad spectrum of quality assurance functions that affect product release, regulatory adherence, and coordination with regional QA teams. The ideal candidate demonstrates advanced technical knowledge, enhanced decision-making authority, and a comprehensive understanding of quality systems.

 

WHAT YOU WILL DO 

 

• You will be responsible for the review and approval of Bills of Materials (BOMs), which directly impacts product composition, labeling accuracy, and regulatory compliance.
• You will be responsible for releasing and controlling non-conforming finished goods (FG) holds, including evaluating supporting data, coordinating with QA and production, and documenting final disposition decisions.
• You will be responsible for updating data for the S&OP Team and addressing queries related to releases.
• You will collaborate with other regions’ QA teams regarding Certificates of Analysis (CoAs), including investigation of discrepancies, clarification of test results, and resolution of documentation issues.

• You will review and follow up on production discrepancies identified in batch records or associated documentation, ensuring timely closure and proper root cause documentation. Support the investigations as required.

• You will apply quality principles, technical evaluation, and cross-functional judgment related to product release and GMP compliance.
• You will prepare master production records for all OTC products.
• You will be responsible for reviewing raw materials, packaging materials, in-process materials, and finished product specifications to ensure GMP compliance, including the reconciliation of OTC batch records.
• You will be responsible for reviewing production batch records and control records for OTC products, initiating investigations into any unexplained discrepancies identified during this process. Additionally, you will prepare Certificates of Manufacturing and Compliance and oversee the release of OTC products for shipment.
• You will file and maintain batch production and control records for OTC product.
• You will conduct/review the Annual Product Review of OTC products.
• You will responsible for preparing the annual CARES Act product list, to submit to FDA.
• You will assist in Internal/External Quality Audits, report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
• You will assist in the change request process.
• You will be responsible to prepare the Product destruction list and collecting the proof of destruction.
• You will provide GMP Training to other departments as needed
• You will research and prepare data as needed for monthly quality metrics reporting
• You will assist with any project/task assigned by the Manager.

 

WHO YOU ARE 

 

• You have a bachelor’s degree (B. A.) from four-year college or university, preferably with a Engineering or Science major.
• You have three years’ knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
• You have a good understanding of 21CFR (Part210-211), ICH guidelines
• You have experience with SAP systems
• You are an expert in Excel and PowerPoint presentation.
• You have good verbal and written communication skills

 

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