Quality Assurance Specialist

Job Description

Job Description

We are a consumer products company in the healthcare field.

Summary of Position:

Performs batch record review and determines disposition of final product. Ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, and PBA Standard Requirement Documents. Performs key functions in support of the QMS and works with the Quality Team by helping to perform tasks for ongoing projects: coordination, organization of files, distribution of tasks, and project status tracking. Consults with Quality Management to discuss effective plans for resolving major quality, production, and efficiency problems.

Essential Duties and Responsibilities:

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Prepare and/or maintain technical files, as necessary, to obtain and retain product approval documentation and disposition.

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Review and approve data for determining the disposition of GMP material (raw material, in-process, finished product, packaging, labeling, and manufacturing components).

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Perform Quality Assurance issuance, review, and approval of production and development batch records and documents. Assign QA release status and disposition to approved finished products.

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Perform and assist with the management, review, and approval of required QMS functions/activities, including but not limited to: Document Control, Training, Complaints, Change Control, Nonconformance, Deviations, CAPA, OOS/OOT, and technical documentation ensuring compliance with PBA and industry standards and regulations.

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Assist with and participate in any audits or inspections for customers, registrars, or regulatory bodies. Help support the internal audit program.

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Perform historical data analysis and trending, when applicable, for Production and Quality related processes. Generate metrics for key QMS elements.

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Conduct robust root cause analysis for manufacturing investigations, as applicable, documenting the root cause and any corrective and/or preventive actions required.

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Act as a liaison and resource, in support of key Quality related tasks/initiatives, to stakeholders across the organization. Collaborate cross-functionally in support of business objectives and to build a strong Quality culture.

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Prepare internal and external reports analyzing data obtained from customer/consumer-reported cases. Serve as a backup correspondent for calls throughout the lifecycle of a caller’s request, including follow-ups with the escalation team. Identify consumer/customer needs, research issues, resolve complaints/adverse events/inquiries, and provide solutions as necessary.

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Maintain and update (when necessary) Quality Management System documentation to reflect current practices and regulatory changes/requirements.

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Support business and continuous improvement objectives in collaboration with other key business functions as assigned.

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Perform additional tasks and assignments as requested by management. Assists with other QA related functions and responsibilities (Environmental Monitoring, Vendor Qualifications, etc.) as requested.

Duties and Responsibilities listed above are required, however not limited to the job operation.

Company Description

We are a staffing firm looking to help people find the right match for their career goals!

Company Description

We are a staffing firm looking to help people find the right match for their career goals!