Senior QA Specialist

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.

Who you are:

• You hold a Bachelor's Degree (preferably in Science or Engineering related fields) with at least 8 years of experience in the pharmaceutical industry.

• You have extensive knowledge of analytical methods, instrumental technologies, method validation, or inspectional procedures for materials.

• You have an in-depth understanding of cGMP, regulatory requirements and quality management systems.

• You have excellent communication skills and the ability to inspire and motivate a team.

• You have experience implementing and driving a continuous improvement culture.

• You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.

Preferred:

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

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $94,000 to $174,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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