Our client is looking for a driven and talented individual to join the Quality Control team in San Carlos, CA as they change the future of oncology. The QC Data Reviewer will report to the Director of Quality Control and will be responsible for ensuring compliance with internal quality systems, policies and procedures and in accordance with US and international regulatory agencies, ICH, general cGMP and international guidance. While collaborating with cross- functional departments, this will be a key role in maximizing our technology and progressing our novel therapeutics to the next phases.
Responsibilities
- Data Review of Raw Material, Release and In-Process testing, Stability, Cleaning Verification samples, Microbiological testing, and Analytical test method Qualification/Verification/Transfer/Validation
- Review the data to comply with cGMPs, GDP, FDA, EMA and ICH Guidelines
- Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP and to increase efficiency, compliance, and quality
- Review analytical data to ensure ALCOA+
- Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data
- Review time of use logs on cGMP instrumentation and other analytical equipment. Review audit trails on computer systems used to acquire and process data from instrumentation (e.g., Chromeleon, Labx). Ability to use a computer to accurately to analyze data and generate reports as needed
- Strong technical knowledge of various analytical equipment, techniques, and methodology (e.g. liquid chromatography, pH, iCIEF, ELISA, SEC, CE-SDS, TAMC)
- Strong prioritization, organizational skills and detailed oriented. Coordinate and discuss with other team members for continuous improvement of the data review process. Discussions and provide suggestions to QC analysts for continuous improvement of the GDP within cGMP requirements and applicable written SOPs, test procedures and methods Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks
- Assist the audit of QC Laboratories (Chemistry, Microbiology) on a routine basis and report directly to department head
- Assist in writing/reviewing QA events/deviations/Investigation when required
- Interaction with QC Analysts and Group Leaders as well as managers of other departments as needed
- Able to work as a team member with the QC Lab environment
Qualifications
- Minimum Education: Bachelor’s degree or higher in scientific discipline required
- Minimum of 5+ years relevant work experience in Quality Assurance/Data review of QC in a pharmaceutical industry
- Experience in Clinical and commercial products is preferred
- Communicate with others clearly and concisely, ability to work in a fast-paced environment
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills
- Knowledge of Quality Management Systems and LIMs systems
- Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
- Ability to effectively train others on programs and procedures
- Experience working with cross-functional teams/sites
