Quality Assurance Specialist

The Opportunity

We are seeking a motivated and experienced Quality Assurance Specialist to join the Synthetic Molecule Analytical Chemistry (SMAC) department in Genentech Research and Early Development on the South San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group.

This role will be responsible for:

• Qualification of GMP equipment and associated compliance documentation, writing qualification protocols, working with QA to obtain protocol approval, and executing validation activities.

• Manage equipment lifecycle activities and documentation such as system risk assessments, decommissioning, and periodic review; serving as department SME for data migration and archival; initiating, planning, and implementing Change Control records as Change Owner as needed; and supporting GMP audits as equipment validation and compliance SME.

• The specialist will work with vendors to provide instrument maintenance and troubleshooting and in-lab equipment and facility support, and act as the deputy lab manager as needed.

• The successful candidate will work in a highly collaborative environment to utilize their technical and communication skills in partnership with analytical chemists and QA to solve complex challenges in SMAC. Hands-on experience and knowledge of technologies such as HPLC, GC, MS, KF, spectroscopy, dissolution and related software will be used to support the daily operations and GMP compliance of our state-of-the-art analytical labs and instruments.

Who You Are

• BS in Chemistry or relevant disciplines in a technical field with a 2-8 years relevant experience in the pharmaceutical/biotech industry

• Hands-on experience in GMP equipment qualification, life-cycle management, and compliance documentation

• Good understanding of cGMP compliance, quality assurance, change control, data integrity, and good documentation practices

• Broad knowledge and experience with analytical instrumentation (HPLC, GC, MS, KF, spectroscopy, dissolution, etc.) including regular maintenance and troubleshooting

• Demonstrated learning agility, adaptability, collaborative skills and delivering results through teamwork

• Proactive and effective communication with client groups

• Leadership skills in identifying opportunities and taking initiatives to improve systems, processes, and workflows

• Excellent organizational skills and attention to detail

Preferred

• Knowledge of Empower software and IT support of data systems is preferred

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $89,100 - $165,500. Actual pay will be determined based on experience, 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.

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.