Quality Assurance Specialist/Senior QA Specialist, Investigations

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 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity:

In this exciting role, you will provide direct manufacturing quality oversight at HTO. As part of a dynamic and inclusive team, you will partner with manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of aseptic drug product manufacturing processes, health authority expectations and industry standards. You will act as a mentor and coach for the organization.

• You will act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products. 

• You will ensure that investigations are accurate, include appropriate corrective actions, and follow company standards.

• You will apply your in-depth practical and conceptual knowledge in the manufacturing and quality functional areas at the site and within the company network.

• You will support internal cGMP audits and Health Authority inspections.

• You will develop new approaches to complex problems potentially influencing others to change their point of view and leading others to solve the problem through coaching conversations.

• You will work independently within broad guidelines and policies, with guidance in only the most complex situations

Who you are:

• You hold a Bachelor’s degree (preferably within the Life Sciences or Engineering)

• For a QA Specialist, you have at least 5 years of experience in the pharmaceutical industry. For a Senior QA Specialist, you have at least 8 years of experience in the pharmaceutical industry.

• You have in-depth industry experience in aseptic GMP Drug Product filling and quality oversight for manufacturing processes and discrepancies

• Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information.

• You are able to gown into production space. 

Preferred:

• You have a Master’s degree (preferably within the Life Sciences or Engineering) 

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $75,000 - $139,400 for the QA Specialist level and $91,100 - $169,100 for the Senior QA Specitalist. 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.

Link to Benefits

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

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