QC Lab & Doc Specialist

Overview

Position Summary
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This position is a hybrid of two roles, covering tasks and duties as required by business and departmental needs.

Under the direction of departmental management, reviews documentation and raw data to ensure compliance with the OECD Principles of Good Laboratory Practice, established Standard Operating Procedures (SOPs) and other applicable regulatory requirements. In addition, prepare documentation to support sample analysis and method validation projects (study/validation plans, sample analysis and/or validation reports) while ensuring compliance with the OECD Principles of Good Laboratory Practice, established SOPs and other applicable regulatory requirements.

• Review all data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidance.
• Coordinate various project activities with other departments such as QA, PK/Stats, Project Management, Business Development and resolve all issues in a very efficient and timely manner.
• Provide feedback and findings regarding documentation discrepancies to departmental management and/or Study Director in a timely fashion.
• Prepare bioanalytical tables, reports and plans and assist with deficiency questions from regulatory agencies when asked.
• Be involved in any audits performed by external auditors.

• Prepare Analytical Procedures (APs), Study Plans and Method Validation Plans as required.
• Write Bioanalytical Study Reports following eCTD guidelines and compile associated summary data tables when required.
• Write Method Validation Reports and compile associated summary data tables when required.
• Participate in archiving, compiling study documents, photocopying and scanning of bio-study documents as required.
• Ensure that all documentation is accurate and in accordance with SOPs and regulatory guidance.
• Provide feedback and findings regarding documentation discrepancies to the departmental management and/or Study Director.
• Conduct all work in compliance with SOPs, GLP and to observe all regulatory guidelines.
• Ensure accurate and complete documentation of all bioanalytical study source documents and/or forms according to company's SOPs, GLP and other applicable guidelines.

• Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
• Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
• Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
• Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.

• B.Sc. in Analytical chemistry or related subject or College Diploma in chemical engineering or related subject
• Some related experience is preferred.
• Must be able to work well with little supervision and effectively in a team.
• Exhibits good interpersonal skills, written skills, a professional attitude, and motivation to produce consistently high-quality work.
• Have flexibility to work long hours, to stay late, or come in over weekends to ensure deadlines are met, on an irregular or as-needed basis to ensure project/study deliverables to other stakeholders are met.