Quality Assurance Specialist

JFC Global is looking for a Quality Assurance Specialist for a client in the York, PA area. The Quality Assurance (QA) Specialist plays a key role in ensuring the quality and compliance of products shipped from the Glen Rock facility. This individual manages product release activities, including reviewing production records and preparing certification documents to meet company standards and external regulatory requirements. The role also involves overseeing document control and training systems and maintaining regulatory files.

Responsibilities:

• Conducts thorough reviews of production records to ensure compliance with internal policies and regulatory expectations.
• Prepares and verifies quality certifications for outgoing shipments.
• Monitors product disposition to ensure timely shipment approval.
• Identifies and documents nonconformance issues, collaborating with various departments to resolve discrepancies.
• Maintains organized records of batch documents and release certifications.
• Manages the document control platform to ensure document accuracy, proper formatting, and adherence to company procedures.
• Provides training and support to team members on system usage and assists with system updates and validations.
• Conducts internal audits and supports external audits as needed.
• Tracks and reports quality metrics to management.
• Manages regulatory submissions and updates for Drug Master Files (DMFs).
• Utilizes electronic quality management tools to manage materials impacted by quality issues.

Requirements:

• Associate's or Bachelor's degree in a scientific or technical field (e.g., Biology, Chemistry) with at least one year of relevant experience, or five years of experience in a regulated industry (e.g., pharmaceuticals, medical devices).
• Familiarity with ISO 9001 or ISO 13485 environments is preferred.
• Strong communication and organizational skills.
• Proficiency in Microsoft Office applications (e.g., Outlook, Excel, Word).
• Experience with quality management or enterprise resource planning systems (e.g., TrackWise, Veeva, Oracle) is an advantage.

EOE
Not ready to apply or have questions? Contact Kelly Barth at 717-761-8095 ext 1175 or kbarth@jfcglobal.com for a confidential conversation.