Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)

Genentech; Oregon, Hillsboro (IL, OR); On-site; USD 94,000 - 174,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen engagierten QA-Spezialisten, der für die Qualitätssicherung in der pharmazeutischen Produktion verantwortlich ist. In dieser spannenden Rolle werden Sie als Fachexperte für aseptische Praktiken und Kontaminationskontrolle tätig sein. Sie werden eng mit verschiedenen Abteilungen zusammenarbeiten, um sicherzustellen, dass die höchsten Qualitätsstandards eingehalten werden. Diese Position bietet die Möglichkeit, an der Entwicklung lebensrettender Medikamente mitzuwirken und Teil eines dynamischen Teams zu sein, das sich der Verbesserung von Patientenversorgung und -sicherheit verschrieben hat. Wenn Sie eine Leidenschaft für Qualität und technische Exzellenz haben, ist dies die perfekte Gelegenheit für Sie.

Benefits

Umzugskostenübernahme

Jährlicher Bonus

Gesundheitsleistungen

Karriereentwicklungsmöglichkeiten

Qualifications

• Mindestens 8 Jahre Erfahrung in der pharmazeutischen oder biopharmazeutischen Industrie für Senior QA.
• Mindestens 11 Jahre Erfahrung oder gleichwertige Kombination für Principal QA.

Responsibilities

• Bereitstellung von Qualitätsaufsicht für Kontaminationskontrollstrategien.
• Unterstützung bei Validierungsaktivitäten für neue Einrichtungen und Versorgungsanlagen.

Skills

Qualitätsüberwachung

Aseptische Praktiken

Entscheidungsfindung

cGMP-Kenntnisse

Problemlösungsfähigkeiten

Zusammenarbeit

Education

B.A. oder B.S. in Lebenswissenschaften

Job description

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 2 manufacturing units, 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 be part of a highly engaged team committed to delivering high-quality medicines to patients. You will provide Quality oversight for the contamination control strategy, aseptic operations, and microbiology. You will serve as a subject matter expert (SME) and resource for the site on aseptic principles including disinfection, environmental control, and monitoring.

• You will provide guidance to internal and external customers on best practices for executing consistent, reproducible, and compliant contamination control strategies and remediations.
• You will support validation activities for new facilities and utilities.
• You will provide technical assessment and approval for changes to the contamination control strategy.
• You will provide Quality authorization for facility and utility restarts following construction or maintenance to ensure environmental control and monitoring.
• You will contribute to investigations and deviations involving suspect equipment, utility, or facility failures.
• You will support the development and preparation of regulatory submissions related to contamination control and environmental monitoring.
• You will assist in training Manufacturing and Quality staff on aseptic practices, processing, and media fills.
• You will collaborate with departments to ensure efficient execution of environmental control and monitoring activities, including nonroutine tasks.

Who you are:

• You hold a B.A. or B.S. degree, preferably in a life science.
• For the Senior QA Specialist level, a minimum of 8 years' experience in the pharmaceutical or biopharmaceutical industry is required. For the Principal QA Specialist level, at least 11 years' experience or an equivalent combination of education and experience.
• You can interpret and relate quality standards for implementation and review.
• You possess sound decision-making skills regarding Quality and technical subjects.
• You have strong knowledge of cGMPs or equivalent regulations.
• You are flexible in problem solving and work hours to meet business objectives.
• You have technical expertise in aseptic practices, processing, cleanroom behaviors, and contamination control strategies.
• You can establish rapport and collaborate effectively with clients, team members, and partners.

The salary range for this position in Hillsboro, OR is $94,000 - $174,000 for Senior level and $114,000 - $211,900 for Principal level. Actual pay depends on experience, qualifications, location, and other factors. A discretionary annual bonus may be available. Benefits information is available via the provided link.

Relocation benefits are provided.

Genentech is an equal opportunity employer. We prohibit discrimination based on protected statuses. If you need accommodations during the application process, please contact us through the provided form.