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Laura V. Pérez Santos

Laura V. Pérez Santos

Quality Assurance Manager

Premier Brands of America Inc.

Greater New York City Area, us

Exceptional planning, organizational and management skills. Ability to write technical documents including processes, procedures and training manuals. Ability to work independently and in a team setting; diverse cross functional groups and situations. Excellent written and verbal communication skills.

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Premier Brands of America Inc.

Quality Assurance Manager

• Management of all Quality Assurance/Control affairs responsibilities
• Quality Management System – Annual review, update, maintenance, training and ensure overall FDA/cGMP compliance
• Quality Assurance / Control Continuous Improvement projects
• QA/QC (Executive) Reporting / Metrics
• PBA 3rd Party Audit Program (cGMP/Ethical) – Coordinate, audit preparation, CAPA’s
• Annual Product Review (APR)
• QA/ENG Change Control Process (Review/approve product, process and equipment changes)
• QA support for new product initiatives (NPD/NBE)
• Material Review Board
• Vendor Qualification Program (Internal / External)
• Supplier Quality Performance Metrics
• (Supplier) Quality Agreements
• NBE 3rd Party Testing (STR/BV)

Premier Brands of America Inc.

Quality Assurance Specialist

• Establish and maintain Quality Management System and RCP cGMP certification. Perform internal and external process audits as necessary. Certification score improvement of 50%.
• Maintain continuous improvements in assurance by conducting internal production / process and quality audits and risk audits to ensure compliance with in-house and external specifications and standards. Ie: FDA Regulations (cGMP) as per product categories: OTC Drugs, Medical Devices, Cosmetics and Non-Regulated products.
• Actively develop, recommend, and administer quality control techniques to ensure all products meet established quality standards, liaising with operations and contract manufacturing suppliers.
• Evaluate the impact of deficiencies in current processes or the adherence to current processes on quality (by observing KPIs, incidents and complaints), work with associated departments to rectify these issues.
• Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
• Develop, maintain, track Supplier Qualification Program: Annual cGMP Compliance Questionnaire, Annual 3rd Party Audit, Annual Social Compliance Audit.