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 proced... more details
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.
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.