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We are looking for a Quality Control Auditor! As a Quality Control Auditor, you will be responsible not just operational necessities; they are cornerstone elements of our strategic commitment to excellence in clinical research by ensuring the accuracy of patient documentation and adherence to the highest standards of quality and regulatory compliance. you are also responsible for:
- Data Review: Conduct thorough reviews of clinical trial data for accuracy, completeness, and compliance with the protocol and standard operating procedures (SOPs). This includes checking case report forms (CRFs) against source documents, verifying consent forms, and ensuring proper adverse event reporting.
- Protocol Adherence: Ensure that the clinical trial is conducted in strict adherence to the protocol, GCP guidelines, and regulatory requirements. This involves monitoring study activities to confirm that they align with the study plan.
- SOP Compliance: Verify that all aspects of the trial are conducted in accordance with relevant SOPs. This includes the management of the trial site, data handling processes, and reporting mechanisms.
- Data Integrity: Ensure the integrity of trial data through regular checks and validations. This involves identifying and resolving discrepancies, missing data, or any inconsistencies in the collected data.
- Training and Support: Provide training and support to clinical trial staff on QC procedures and protocols. Ensure that all team members are aware of their responsibilities regarding quality control.
- Continuous Improvement: Identify areas for improvement in the trial process and contribute to the development and updating of SOPs and QC standards.
- Reporting: Prepare and submit regular QC reports to the quality assurance team, highlighting any issues or deviations from the protocol and suggesting corrective actions.
Requirements
What were looking for
- Working knowledge of tools, methods, and concepts of Quality Control or Clinical Research
- Solid knowledge of relevant regulatory standards
- Good communication skills, both verbal and written
- Excellent data collection and analysis skills
- A keen eye for detail and a results-driven approach
- Ability to work in a team-fostered environment.
- Ability to prioritize and organize work in a multitasked environment..
- Ability to maintain the highest level of confidentiality.
- Thorough knowledge of quality control standards and testing methodologies
- Substantial experience in clinical research or quality assurance is essential. Previous roles as a Clinical Research Associate (CRA), Quality Control Officer, or similar positions can provide valuable experience.
- Strong auditing skills, including the ability to plan, conduct, and report on internal and external audits. Familiarity with audit methodologies and tools is important.
Benefits
- Government-mandated contributions: SSS, Philhealth, PagIBIG
- 13th month pay: computation is based on the basic salary of the employee
- Perks and/or Allowances: Deminimis (non-taxable), benefits of relatively small value intended for the general welfare of employees (Power and Internet Allowance, Meal Allowance, Rice Allowance, Clothing Allowance, Laundry Allowance, and/or Medical Cash Allowance)
- Paid Leaves: 6 VL to take time off, 6 SL (recuperation), 3 EL (emergency situations), statutory leaves (maternity, solo parent, maternity, etc)
- Leave Conversion: maximum of 10 unused leave credits may be converted into cash
- Special Leave Privileges: birthday occasions, client-initiated leaves
- Healthcare Benefit with one (1) dependent
- Funeral Assistance: Php 5,000
- Service Award Incentive: rewards and recognition for employees who will successfully reach 1, 3, 5, 7, or 10 years with the company
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Last updated on Feb 29, 2024