Senior Lab Analyst(ISO 17025, cGMP, Cell Testing)

OAKTREE CONSULTING; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading consulting firm in Singapore seeks a QC Microbiologist to lead laboratory operations and ensure compliance with ISO 17025 and cGMP standards. The ideal candidate will have 2-6 years of QC microbiological experience, engaging in method development and validation, while providing technical leadership and mentoring to the team. This role requires strong analytical skills and the ability to work collaboratively. Interested candidates may submit their resumes to the provided email.

Qualifications

• Minimum 2-6 years of relevant QC microbiological experience.
• Experience in method validation and development.
• Good knowledge of ISO 17025 and cGMP guidelines.

Responsibilities

• Lead method development and validation.
• Evaluate analytical results for projects.
• Ensure compliance with regulatory requirements.

Skills

Technical leadership

Method development

Analytical evaluation

Scientific communication

Problem-solving

Team collaboration

Process improvement

Education

Bachelor of Science or related field

MSc (preferred but not essential)

Job description

Overview

POSITION SUMMARY
This role is responsible for ensuring the laboratory operations in accordance to ISO 17025 and cGMP requirements. He/She will serve as analytical lead in variety of projects which includes but not limited to method validation, method transfer, customized testing activities. In addition, this individual is responsible for directing the day-to-day project activity through interaction with technical personnel while gathering, analyzing and interpreting scientific data. He/She must ensure accurate and precise results are being achieved and properly reported.

Duties & Responsibilities

• Provides strong, independent technical leadership to technical personnel
• Leads, designs and performs method development (i.e. bioassay and mycoplasma) and validation of new test procedures for incoming projects
• Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
• Evaluates analytical results to form interpretations of data and renders scientific opinions for client-driven projects
• Serves as subject matter expert (SME) in area of specialization, established standards for regulatory compliance
• Serves as technical liaison with Customers with regards to technical services and performs Customer site visits where required
• Prepares documents including methods, procedures, standard operating procedures (SOP), study protocols, summary reports
• Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements
• Provides problem-solving skills for test procedures and investigations within laboratory unit
• Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in a timely manner
• Monitors all proficiency-based testing and ensures compliance
• Participates in internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities
• Participates in quarterly management review
• Drives process, quality and safety improvement initiatives within the department
• Provides coaching and mentoring to Technical personnel
• Supports the Laboratory Manager in all relevant functions

General requirements

• Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.
• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
• Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
• Performs all other related duties as assigned.

QUALIFICATIONS

• Bachelor of Science or any related field; MSc. preferred but not essential
• Minimum 2-6 years of relevant QC microbiological experience working in an ISO17025 / GMP laboratory environment
• Experience in method validation and development, method transfer, qualification activities in regulated laboratory
• Good knowledge of ISO 17025, cGMP and other regulatory guidelines
• Good understanding/working knowledge of Project Management and Measurement Uncertainty (MU)
• Good technical understanding and judgement
• Good interpersonal and communication skills across cultures
• Team player with ability to work in cross-functional teams as well as independently depending on requirement of task on hand

Please submit resumes to [e-mail]

- Position applying for

- Current remuneration

- Expected remuneration

- Notice period

John Goh Meng Chye

EA License No : 06C4642

EA Reg No : R1102621

We regret that only shortlisted candidates will be notified.