JOB SCOPE:
Client is seeking a data reviewer at Specialist level for Quality Control Chemistry laboratory. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support protocol testing data review and special projects as needed.
Here’s What You’ll Do
• Performs routine analytical chemistry data review for the data generated through the laboratory tests including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc.
• Perform data review in LIMS and/or in paper worksheets to meet the project timeline.
• Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.
• Ensure stability data review completed within the required timeline.
• Actively support OOS, OOT, OOE and LE investigations and be able to write investigation reports.
• Participate quality event investigations such as deviations, change controls, CAPAs, effectiveness check author the related documents, coordinate with QA, and follow through the event closure as needed
• Ensure laboratory data integrity comply with US and international regulatory requirements
• Interact with other analysts when corrections are identified as part of the data review process.
• Supports troubleshooting of methods and equipment.
• Performs data entry and supports trending and regulatory submission as applicable.
• Support Certificate of Analysis generation as needed.
• Participates in project meetings to provide status updates to stakeholders
• Provides prompt communication of risk and mitigation for all data management related deliverables.
• Assist in regulatory, customer and internal quality audits that involve data review and data management.
• Assist in test scheduling as necessary (e.g., when tests needs to be repeated based on data review) to meet the project timelines.
• Work on identifying procedure gaps, continuous improvement for data review requirements and processes to ensure delivery of highest quality of data
• Provide appropriate SME training for the department
• Maintain and manage cGMP documentation (electronic and Hard Copy) for laboratory raw data packets.
• Write/revise SOPs, protocols and reports if applicable
• Establish and maintain a safe working environment
• Additional duties as may be assigned from time to time
Here’s What You’ll Need (Minimum Qualifications)
• Minimum education required: Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
• Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry
Here’s What You’ll Bring to the Table (Preferred Qualifications)
• Have in-depth understanding of the clinical and commercial product life cycle process and the corresponding cGMP pharmaceutical data management and regulatory cGMP/GDP compliance
• Solid scientific and technical breadth to support analytical test methods used in a biopharmaceutical manufacturing facility
• Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
• Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC./GC. Be able to provide in-depth training of proper chromatographic integration to lab analysts.
• Strong chromatographic (LC/GC) experiences and troubleshooting skills
• In-depth knowledge and expertise in method transfers/qualifications/validations
• Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
• Strong communication skills as well as organizational skills
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment while maintaining good quality
• Details and results oriented
• Solid technical writing and data interpretation skills.
• Outstanding ability to multi-task
• Highly independent and self-motivated
• Strong sense of urgency
• Ability working under pressure while maintain high quality
• Ownership to the projects and commitment to meet the timelines
• Solid knowledge of lab safety
• Highly proficient use of Microsoft Word and Excel, Chromatographic Software
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
MA: QC DATA REVIEWER (232754)
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