Job Summary:

• Control quality of reports, presentations and data files
• Writing and editing protocols, and reports, for GLP and non-GLP studies
• Writing and reviewing of GMP protocols and reports
• Processing of raw data from instruments
• Review and posting of documents to document management system
• Data processing and organization for reports
• Tracking of metrics to improve production and efficiency
• Know regulatory requirements, operational, and administrative procedures

Skills on Resume:

• Quality Control (Hard Skills)
• Protocol Writing (Hard Skills)
• Data Processing (Hard Skills)
• Document Posting (Hard Skills)
• Report Organization (Hard Skills)
• Metrics Tracking (Hard Skills)
• Regulatory Knowledge (Hard Skills)
• Administrative Skills (Soft Skills)

Job Summary:

• Verifying all laboratory documents such as laboratory notebooks, laboratory result sheets, certificates of analysis and calculation worksheets that are generated by the laboratory.
• Review all technical reports generated in the laboratory
• Review of all documentation related to the validation, verification and calibration of laboratory instruments and equipment.
• Verifying all laboratory results ensuring accuracy, integrity and traceability of supporting raw data are produced in accordance with GLP and GMP, testing method and standard operating procedures.
• Notify the departmental manager and/or manager of Quality regarding omissions, incomplete results, or any irregularities.
• Assist managers during investigations of OOS results and consult the departmental manager regarding omission, deviation, incomplete results, and other irregularities.
• Verify the integrity and traceability of all data generated and reported.
• Communicate effectively with departmental managers, colleagues, and QA.
• Effectively works in a team and demonstrates a commitment to achieving company goals.
• Efficiently prioritizes assigned daily workload and uses time productively.
• Assists with the training and development of data reviewers
• Ability to perform with a high degree of independence.
• Serves as a professional and positive role model for the department
• Attend all applicable study, project, and department meetings.

Skills on Resume:

• Document Verification (Hard Skills)
• Technical Reporting (Hard Skills)
• Instrument Calibration (Hard Skills)
• Data Integrity (Hard Skills)
• Quality Communication (Soft Skills)
• Team Collaboration (Soft Skills)
• Training Development (Soft Skills)
• Independent Performance (Soft Skills)

Job Summary:

• Overall responsibility for the data review of QC/AD/Metrology and contract lab analytical data.
• Ensure all analytical testing performed is documented in accordance with SOP requirements.
• Assist in the revision and development of documentation related to the Lab Operations functions.
• Coach and train Chemists and provide analytical and Empower 3 user expertise.
• Complete special projects and assignments and continued personal development.
• Recognize OOS or out of trend results and under the direction of the Supervisor assist in the completion of lab investigations.
• Collaborate with other departments to proactively build quality into the processes and systems.
• Provide support for Internal and Regulatory Inspections.
• Complete all GMP documentation correctly and promptly.
• Complete all training assignments within assigned timelines.
• Conduct (participate or lead) routine laboratory and Non-Conformance Investigations.
• Initiate and follow through with actions required to close Change Controls.
• Evaluate methods and procedures and suggest improvements and changes 

Skills on Resume:

• Data Review (Hard Skills)
• SOP Compliance (Hard Skills)
• Documentation Development (Hard Skills)
• Chemist Training (Soft Skills)
• Project Management (Soft Skills)
• Quality Collaboration (Soft Skills)
• Inspection Support (Hard Skills)
• Change Management (Hard Skills)

Job Summary:

• Guarantee accurate review and corrections in accordance with Good Laboratory Practice (GLP), Standard Operating Procedures (SOP) and study plan.
• Ensure that all pertinent data is reviewed.
• Ensure that the data are complete and consistent for tabulation according to the study design and SOPs.
• Be able to finalize the review and corrections on time within the time limits prescribed by the SOPs and also the predetermined dates for each project.
• Be proactive in obtaining the information necessary to correct and write deviations in relation to the revised data.
• Assemble all the data at the end of each study and send the books to the Dataroom according to the required dates.
• Perform timely reviews of cGMP data from HPLC, ELISA & capillary electrophoresis with a strong focus on data quality/ integrity
• Verify calculations and documented information are complete and accurate
• Verify analysis performed as per the methodology and in compliance with GMP
• Maintaining and developing understanding of CGMP and all other regulatory requirements
• Maintain and update knowledge of instrumentation including HPLC, ELISA & CE

Skills on Resume:

• GLP Compliance (Hard Skills)
• Data Review (Hard Skills)
• Deadline Adherence (Soft Skills)
• Deviation Management (Hard Skills)
• Data Assembly (Hard Skills)
• Quality Verification (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Instrument Proficiency (Hard Skills)

Job Summary:

• Compile data/documentation from Laboratory notebooks and data acquisition systems (Open lab, Total Chrom, LIMS, Spectra, etc.)
• Review the raw data files of laboratory data.
• Review audit trail to ensure data integrity of the laboratory data prior product release.
• Prepare the finished product Certificate of Analysis upon completion of the data review and audit trail review.
• Work with product release team and laboratory management to meet deadlines for final product releases.
• Support management by providing documentation for audits 
• Perform and review qualification of laboratory data acquisition systems
• Ensure data integrity of the data generated by the lab
• Provide necessary trainings and guidance to lab personnel on data integrity and GDP 
• Review data from various laboratory analytical instruments and generate reports templates.
• Ensure control checks of laboratory data meet quality assurance guidelines.
• Perform data comparisons of raw and processed data to reported data.
• Proofread analytical reports to ensure correct information and data are recorded.
• Accurately transcribe or translate results into various formats and reports for clients.

Skills on Resume:

• Data Compilation (Hard Skills)
• Audit Trail Review (Hard Skills)
• Certificate Preparation (Hard Skills)
• Release Coordination (Soft Skills)
• Audit Support (Soft Skills)
• System Qualification (Hard Skills)
• Training Delivery (Soft Skills)
• Report Proofreading (Hard Skills)