2027 Summer Intern - External Quality (PTQX)

Genentech • South San Francisco, CA • 5h ago

The Position

Department Summary

External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient's right, as well we leverage external partners to offer flexibility to our internal capacity at the correct cost and quality, we enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide, and do this through cross-functional collaborations, ensuring quality process excellence and continuous improvement.

This internship position is located in South San Francisco, on-site

The Opportunity

Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements.

Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.

Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions.

Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.

Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.

Program Highlights

Intensive 12 months, full-time (40 hours per week) paid internship.

Program start dates are in June (Summer).

A stipend, based on location, will be provided to help alleviate costs associated with the internship.

Ownership of challenging and impactful business-critical projects.

Work with some of the most talented people in the biotechnology industry.

Who You Are (Required)

Required Education

You meet one of the following criteria:

Must have attained a Bachelor's Degree (not currently enrolled in a graduate program).

Must have attained a Master's Degree.

Must have attained a PhD.

Required Majors: Biochemistry, Biochemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, Engineering.

Required Skills

Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.

Ability to interpret quality standards as they relate to GxP suppliers.

Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.

Fluency in oral and written English is a must.

Preferred Knowledge, Skills, and Qualifications

Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus.

Experience with GxP suppliers such as CMO, CLO, and direct material suppliers is a plus.

Additional language skills are a plus.

Operational Excellence expertise is a plus.

Excellent communication, collaboration, and interpersonal skills.

Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of California is $28.00-$47.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.

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.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .

Similar Jobs

Senior Fund Accountant, Asset Management

Robert Half • San Francisco, CA • 17min ago

Finance, Accounting & Banking

Description Reach out to Michelle Espejo via email or LinkedIn for additional information or questions regarding this listing. Senior Fund Accountant | Asset Management Firm | San Francisco; Hybrid (3 days onsite) Join a...

17min ago

Go to Apply

National Channel Account Manager-ePlus,Trace3 and Defy

Proofpoint • San Francisco, CA • 19min ago

Management & Administrative

California Florida New York Texas New Jersey Washington Illinois Massachusetts Georgia Full time R14962 About Us: Proofpoint is a global leader in human- and agent-centric cybersecurity. We protect how people, data, and...

19min ago

Go to Apply

Key Account Manager

Danaher Corporation • Oakland, CA • 25min ago

Management & Administrative

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Molecular Devices, one of Danaher's ( https://danaher.com/our-businesses )...

25min ago

Go to Apply

Territory Account Manager

EquipmentShare • Newark, CA • 27min ago

Management & Administrative

Build the Future with Us - EquipmentShare is Hiring a Territory Account Manager At EquipmentShare, we're not just filling a role - we're assembling the best team on the planet to build something that's never been built b...

27min ago

Go to Apply

Key Account Manager

Danaher Corporation • San Francisco, CA • 27min ago

Management & Administrative

27min ago

Go to Apply

Fund Accounting Manager

Robert Half • San Francisco, CA • 28min ago

Finance, Accounting & Banking

Description Reach out to Michelle Espejo via email or LinkedIn for additional information or questions regarding this listing. Fund Accounting Manager | Leading Investment Management Firm | San Francisco | Hybrid; 1-2 Da...

28min ago

Go to Apply

Tech Ops Lead, AWS Industries Strategy & Operations

Amazon • San Francisco, CA • 48min ago

IT & Engineering

Description AWS Industries Strategy & Operations team is seeking a leader to work with Tech leaders and their teams (SAs and CSMs) across AWS Industries org to build and run critical business management cadences incl...

48min ago

Go to Apply

Assistant Clinical Research Coordinator

Stanford University • Stanford, CA • 1h ago

Hospital & Medical

Job Description Stanford University is seeking an Assistant Clinical Research Coordinator to perform administrative support duties related to the collection of clinical data and/or the coordination of clinical studies. W...

1h ago

Go to Apply

Health Sensing PD - Mechanical Engineer (Optics)

Apple • San Francisco, CA • 1h ago

Hospital & Medical

Role Number: 200693313-3401 Summary The Health Sensing Product Design team is seeking an experienced mechanical engineer to build the next generation of health sensors. Our sensors change how people interact with their t...

1h ago

Go to Apply

Medical Assistant- Cardiology

Sutter Health • Castro Valley, CA • 1h ago

Hospital & Medical

We are so glad you are interested in joining Sutter Health! Organization: SEBMF-East Bay Medical Foundation Position Overview: Provides clinical and clerical support to providers and members of the patient care team(s) b...

1h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)