Sr. Quality Control Associate

The Position

In this position you will Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Conduct non-routine analysis of manufactured products. Calibrate and maintain laboratory and instrumentation equipment. Revise and update standard operation procedures. Develop and/or optimize testing methods and troubleshoot testing methods. Maintain laboratories in audit ready and cGMP compliant manner and participate in audits. Compile data for documentation of test procedures and prepare reports for internal and regulatory submissions. Review and evaluate data for conformance to specifications/reports. Investigate anomalous data. Use state-of-the-art techniques to evaluate and implement new techniques and technologies. Maintain validation program for QC laboratory analytical instruments. Evaluate and trend data and own discrepancies. Provide ongoing training and process improvements. Lead product operations with special projects.

The opportunity:

• Creates, reviews, and approves validation documents.

• Provides process and equipment knowledge and training to QC partners.

• Monitors operations and is responsible for identifying and resolving equipment and process issues

• Support QC with day-to-day requests for validation, maintenance, or user administration on lab instruments.

• Work with key business users to identify new equipment and/or system improvement needs in the laboratories.

• Act as a single point of contact (SPOC) for QC equipment support issues.

• Act as a QC liaison with IT for IT changes for computer-related systems.

• Identify and train in other applications as necessary to support QC activities as a subject matter expert.

• Apply advanced techniques to troubleshoot assay and equipment problems

• Perform microbiological testing and chemical testing at all levels of complexity to support special studies and validations

• Serve as a liaison for daily activities and special projects within QC or cross-functionally

• Act as subject matter expert for assays/areas of technical expertise and provide support to analysts within the department and cross-site

• Perform data review, data trending, report writing, and lab maintenance

• Support QC with Quality reports such as Methods Monitoring, Annual Products Review, APQR, etc.

• Evaluate and implement new techniques and technologies. As well as generating reports from electronic systems

• Identify process improvements to support QC activities as a subject matter expert

• Identify functional improvement needs for laboratory systems or technical equipment

• Applies a complete understanding of theories and concepts from one's technical and/or professional discipline to independently address a broad range of difficult problems

• Represent QC as a subject matter expert during audits by presenting data, validations, and

• other technical information

• Ensures the integration of environmental health, safety, and security into the business

• processes, systems, and programs while reporting safety and environmental incidents

• including injuries, illnesses, and safety suggestions within one's functional area. Fosters a

• positive safety culture in which no one gets hurt.

• Act as supervisor designee in cross-site and/or interdepartmental meetings

• Facilitate team meetings as required

Who you are:

• You hold a Bachelor's Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline.

• And have 7-8 years of related experience.

Knowledge, Skills, and Abilities

• Strong written and verbal communication skills, with demonstrated leadership in a large

• Ability to read and follow Standard Operating Procedures

• Computer skills- LIMS, Microsoft Word, Excel, PowerPoint, Visio

• Work under limited direction and guidance. Ability to invest time, as required, to expedite or

• complete assignments or projects. This shall include working non-standard hours such as

• evenings and weekends as necessary.

• Ability to read, interpret, and troubleshoot technical data.

• Ability to use discretion and good judgment in making decisions, including the ability to know when to refer a problem to senior-level staff.

• Demonstrate strong presentation skills, including the ability to prepare and deliver

• Ability to work in a fast-paced environment with high-volume testing schedules

• Experience speaking to auditors

Work Environment/Physical Demands/Safety Considerations

• All employees with jobs that require access to the Warehouse must be able to pass the

• Transportation Security Administration (TSA) Security Threat Assessment (STA).

• Work in office and laboratory environment.

• And able to lift up to 30lbs

• May work in a clean room environment that requires gowning and no makeup or jewelry

• May work in a clean room environment where it is loud due to different equipment

• operating

• Work with some hazardous materials and chemicals

• Ability to sit, stand, and move within workspace for extended periods

• Ability to perform repetitive tasks, including frequent hand-to-finger manipulations, grasping

• pushing and pulling.

• Ability to stand 8 to 10 hours a day.

• May be required to work some evenings and weekends

Relocation benefits are not available for this job posting.

The expected salary range for this position, based on the primary location of California, is $82,900-153,900 of hiring range. 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.

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.