Roche Quality Control Job – Biology/Microbiology/Biochemistry
Perform adventitious agent testing in support of manufacturing operations, lot release and validation in accordance to standard operating procedures. Collect, process, and report data. Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Conduct routine and 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.
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 discrepancies. Provide ongoing training and process improvements. Support product operations with special projects.
Job Title: Quality Control Associate II
Location Oceanside, California, United States of America
Category Quality
Job Id 202205-120926
Education and Experience
- Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline
- 5-6 years of related experience
Knowledge, Skills, and Abilities
- 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
- Work under general supervision and guidance
- 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
- Excellent aseptic technique
- Experience with electronic systems used in laboratories
- Detail-oriented
- Knowledge of laboratory safety procedures
- Experience working in GMP environment
- Experience speaking to auditors
Job Responsibilities
Essential
- Collect, process and report on data for samples associated with in-process testing from the clinical and/or commercial manufacturing facilities
- Initiate, compile, 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
Perform adventitious agent testing at all levels of complexity to support manufactured products, investigations, special studies, and validations - 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 within department and cross-site
- Perform data review, data trending, report writing, and lab maintenance
- Evaluate and implement new techniques and technologies
Participate in routine projects - Responsible for working independently as well as within a team
- Responsible for collecting, entering data and generating reports from electronic systems
- Manage QC user administration requests for laboratory systems
- Perform day-to-day administration tasks using laboratory systems
- Identify and train in other applications or assays as necessary to support QC activities as a subject matter expert
- Identify functional improvement needs for laboratory systems or technical equipment
- Lead projects requiring technical or project management guidance
- Apply theories and principles from technical and/or professional discipline to independently address a variety of problems of moderate scope.
- All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
- 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.
Supplementary Responsibilities
- Act as designee in cross-site and/or interdepartmental meetings
- Facilitate team meetings as required
- Attends department and corporate meetings
- Attends seminars and/or classes to enhance technical or professional skills
Roche Quality Control Job
