This position offers a great opportunity to contribute to the smooth and efficient operation of the laboratory while ensuring compliance with quality standards. You will be responsible for reviewing and assessing data to ensure it meets specifications and reports. Additionally, you will investigate any unusual or anomalous data. You will also have the opportunity to utilize cutting-edge techniques and technologies to evaluate and implement new methods. And maintaining the validation program for ... more details
The Quality Control Associate I is an important member of the Pilot Plant. They will support day-to-day activities involved in carrying out Process Development experiments with Chinese hamster ovary (CHO) cell culture processes. They will support products from early and late-stage research until post-market optimization to ensure that new processes are robustly designed and successfully transitioned from development to manufacturing. They will coordinate and execute complex process development experiments in close collaboration with Pharma Technical Development customer groups and act as a member of a high-functioning team. Studies executed will support all phases of drug development, process validation/characterization, process and equipment improvements, general troubleshooting, and technology development.
The Opportunity:
This position offers a great opportunity to contribute to the smooth and efficient operation of the laboratory while ensuring compliance with quality standards. You will be responsible for reviewing and assessing data to ensure it meets specifications and reports. Additionally, you will investigate any unusual or anomalous data. You will also have the opportunity to utilize cutting-edge techniques and technologies to evaluate and implement new methods.And maintaining the validation program for analytical instruments in the QC laboratory. This will involve evaluating and analyzing data trends, as well as investigating and providing assessments for any discrepancies that arise.
Lastly, you will have the chance to support product operations through involvement in special projects. These projects may vary, but they will provide valuable opportunities to contribute to the overall success of the team and organization.
You’ll Initiate, compile, own, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information
Apply advanced techniques to troubleshoot assay and equipment problems
Train others in basic to complex laboratory and troubleshooting techniques
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
Perform microbiological testing and chemical testing to support special studies, and validations
Responsible for generating reports from electronic systems
Manage Quality Control user administration requests for laboratory systems
Work with key users to identify functional improvement needs for laboratory systems or technical equipment
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. 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 3-4 years of related experience
Additional Skills:
Demonstrate excellent organizational skills, strong written and verbal communication skills, with demonstrated leadership in a large group
Computer skills- LIMS, Microsoft Word, Excel, Power Point, Visio
Ability to read and follow Standard Operating Procedures
Ability to read and interpret technical data
Ability to work in a fast pace environment with high volume testing schedules
Experience in chemical and microbiological testing assays
Experience in aseptic techniques required for cell handling and sample aliquoting
Knowledge of laboratory safety procedures
Experience working and apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.
Work Environment/Physical Demands/Safety Considerations:
Able to lift up to 30 pounds.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
May work in a clean room environment that requires gowning (PPE) and where it is loud due to different equipment operating.
Work with some hazardous materials and chemicals.
Ability to move and stand within workspace for extended periods. Ability to stand 8 to 10 hours a day.
May be required to work overtime, 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 $23.55-$40.00 hourly in the 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. Benefits
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.
