7042 Senior QC Analyst

$104,000 - $124,800/Yr

Harvest Technical Services - Hillsboro, OR

Full-time - Mid Level

Hillsboro, OR

Administrative and Support Services

About the position

The Senior QC Analyst position at Harvest Technical Services is a critical role that provides direct manufacturing Quality Assurance support for all Good Manufacturing Practice (GMP) activities at the Hillsboro Technical Operations (HTO) and Hillsboro Distribution Center (HDC). This position acts as a key Quality contact for manufacturing, focusing on discrepancy management, batch review, and line support. The Senior QC Analyst is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) regulations, the company's standards, and applicable regulatory requirements. The role requires the ability to resolve Quality Assurance issues and develop solutions for complex problems while adhering to cGMP regulations. The analyst will work independently within broad guidelines and policies, making it essential to have a strong understanding of quality assurance processes and regulatory compliance. In this role, the Senior QC Analyst will provide Quality oversight to the manufacturing operations at HTO, initiating and closing quality event records and action/assessment records as required. The position also advocates for the mission of advancing and boldly championing diversity, equity, and inclusion within the workplace. The analyst will follow company policies and procedures diligently, maintaining a state of inspection readiness at all times. This includes signing documents for activities as a Manufacturing Quality Assurance (MQA) representative, reviewing batch records in the Aseptic Operations, Inspection, and Packaging areas, and completing additional actions in the Discrepancy Management System as assigned. The role requires interaction with interdepartmental contacts on discrepancy assessment and resolution, as well as reviewing and approving controlled documents related to processes, equipment, facilities, and utilities in the manufacture of products. Collaboration with various departments is crucial to ensure that all review activities are executed efficiently and effectively, supporting process improvement initiatives throughout the organization.

Responsibilities

• Provide Quality oversight to the manufacturing operations at HTO.
• Initiate and close quality event records and action/assessment records as required.
• Advocate for the mission of advancing and boldly championing diversity, equity, and inclusion.
• Follow company policies and procedures.
• Maintain a state of inspection readiness.
• Sign documents for activities as MQA as described by The Company's policies, procedures and job descriptions.
• Review batch records in the Aseptic Operations, Inspection, and Packaging areas.
• Complete Additional Actions in the Discrepancy Management System as assigned.
• Interact with interdepartmental contacts on discrepancy assessment and resolution.
• Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
• Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
• Support process improvement initiatives.

Requirements

• Bachelor's or Master's degree (preferably in Life Science or Engineering) with 4-7 years of experience in the pharmaceutical industry and at least 2 years in a quality role.
• In-depth industry experience in aseptic GMP Drug Product filling and quality oversight for manufacturing processes and discrepancy management.
• Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning into production space.
• Knowledge of cGMPs and Health Authority expectations.
• Experience reviewing manufacturing documentation.
• Ability to communicate clearly and professionally both in writing and verbally.