Job Description
- The QC Analyst's main role is to carry out QC analyses in compliance with Laboratory and Analytical Methods ensuring quality, cGMP, health, safety, and environmental standard are met.
- QC Analyst is also involved in other functions such as documentation and preparation of standard operating procedures.
- Perform Carry out analytical testing in compliance with specifications, Analytical Methods, Laboratory Methods, and pharmacopeia requirements.
- Assist in monitor the calibration and maintenance program for laboratory instruments/equipment and ensure compliance with established schedules.
- Assist in the qualification of laboratory equipment and validation of analytical methods.
- Perform the analyses and report results in accordance with GLP (Good Laboratory Practices).
- Completed the analyses on time and consistent with business requirements.
- Assist in conducting OOS and atypical results investigation.
- To ensure that qualification, preventive maintenance, and calibration of laboratory equipment are carried out.
- Report and trend test results.
- Planning and assurance of cGMP compliant quality testing and documentation according to schedule.
- Prepare laboratory reagents in compliance with GLP and laboratory SOP requirements.
- Maintenance and development of all required laboratory documents (i.e. raw data sheets, logbooks).
- Responsible for electronic raw data handling in compliance with regulations and guidelines.
Skills
- Reading Comprehension - Understanding written sentences and paragraphs in work-related documents.
- Science - Using scientific rules and methods to solve problems.
- Attention to Detail - Job requires being careful about detail and thorough in completing work tasks.
- Integrity - Job requires being honest and ethical.
- Dependability - Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Cooperation - Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Adaptability/Flexibility - Job requires being open to change (positive or negative) and to considerable variety in the workplace.
- Analytical Thinking - Job requires analyzing information and using logic to address work-related issues and problems.
- Innovation - Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.
Education
