Senior QA Specialist

Genentech • Hillsboro, OR

286d • $94,000 - $174,000

About The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into two manufacturing units, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: Quality Control works in a very dynamic environment in both the commercial and new product technical transfer environments. The close networking with the local and global organizations makes QC a key function in the end to end business. In this exciting role, you will provide direct quality oversight for the quality control organization at HTO. As part of a dynamic and inclusive team, you will partner with quality control, manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of quality control final and in process drug product testing and environmental monitoring, health authority expectations and industry standards. You will act as a mentor and coach for the organization. You will act as key quality contact for the quality control organization to resolve issues in a timely manner, including discrepancies, investigations, and implementation of corrective and preventative actions (CAPA). You will escalate potential quality issues identified during QC testing or processing of products, particularly quality or regulatory issues that could impact product quality or regulatory compliance. You will establish, modify, implement and carry out quality control policies, procedures, specifications and testing methods consistent with cGMP, regulations, relevant regulatory frameworks and Roche/Genentech standards, policies, plans, objectives and procedures. You will apply your in-depth practical and conceptual knowledge in the quality control, manufacturing and quality functional areas at the site and within the company network. You will support internal cGMP audits, regulatory inspections and partner audits. You will coordinate with regulatory authorities and external sources and network partners regarding issues affecting product quality.

Requirements

• Bachelor's Degree (preferably in Science or Engineering related fields).
• At least 8 years of experience in the pharmaceutical industry.
• Extensive knowledge of analytical methods, instrumental technologies, method validation, or inspectional procedures for materials.
• In-depth understanding of cGMP, regulatory requirements and quality management systems.
• Excellent communication skills and the ability to inspire and motivate a team.
• Experience implementing and driving a continuous improvement culture.
• Ability to work in a dynamic and fast-paced environment while ensuring the highest quality and safety standards.

Nice To Haves

• Master's degree with 6 years of experience in the pharmaceutical industry (preferably within the Life Sciences or Engineering).

Responsibilities

• Provide direct quality oversight for the quality control organization at HTO.
• Partner with quality control, manufacturing and other stakeholders to supply patients.
• Apply knowledge of quality control final and in process drug product testing and environmental monitoring.
• Act as a mentor and coach for the organization.
• Resolve issues in a timely manner, including discrepancies, investigations, and implementation of CAPA.
• Escalate potential quality issues identified during QC testing or processing of products.
• Establish, modify, implement and carry out quality control policies, procedures, specifications and testing methods.
• Support internal cGMP audits, regulatory inspections and partner audits.
• Coordinate with regulatory authorities and external sources regarding issues affecting product quality.

Benefits

• Relocation benefits available.
• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree