Quality Assurance Specialist III/Senior, Frontline Technical Lead

Posted 13 Hours Ago
Be an Early Applicant
Hillsboro, OR
75K-169K Annually
Senior level
Healthtech • Biotech
The Role
The role includes acting as a technical lead for frontline manufacturing quality oversight, mentoring staff, developing approaches for complex problems, supporting internal audits and health authority inspections, and providing expertise on new product and asset introductions.
Summary Generated by Built In

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 act as a technical lead for our frontline manufacturing quality team that provides 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 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 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

  • You will support internal cGMP audits and Health Authority inspections 

  • You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.

  • You will serve as a senior quality resource to navigate complex issues, some of them arising from new product and new asset introductions at the site 

Who you are:

  • You hold a Bachelor’s or Master’s degree (preferably within the Life Sciences or Engineering) with 8-11 years of experience in the pharmaceutical industry for a Senior QA Specialist level and 4-7 years of experience for a QA Specialist III level

  • You have in-depth industry experience in aseptic GMP Drug Product filling and/or in-depth Device expertise that make you a recognized expert in your job discipline.

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

  • You have some flexibility in regards to shift coverage and are able to gown into production space

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $75,000 - $139,000 for a level III and $130,100 - $169,100 for a senior level. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

Relocation benefits are provided

#gnehtoquality
 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

The Company
HQ: South San Francisco, CA
20,069 Employees
On-site Workplace
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years.

Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

Making a difference in the lives of millions starts when you make a change in yours.

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