Analyst (Microbiology Laboratory)

SKILLSFORCE MANAGEMENT CONSULTANCY PTE LTD; Singapore; On-site; SGD 20,000 - 60,000; Full time

Job summary

A laboratory services provider in Singapore is seeking a skilled individual responsible for ensuring smooth laboratory operations and leading method development projects. The ideal candidate will have a Bachelor’s degree, QC microbiological experience, and a solid understanding of ISO 17025 and cGMP guidelines. Excellent communication and technical skills are essential. Interested applicants should email their detailed resumes to the provided address.

Qualifications

• Minimum 2-6 years of relevant QC microbiological experience.
• Experience in regulated laboratory environments.
• Good knowledge of ISO 17025 and cGMP.

Responsibilities

• Ensure smooth laboratory operations in accordance with ISO 17025.
• Lead method development and validation tests.
• Provide technical liaison with customers.

Skills

Technical leadership

Method validation

Communication skills

Project Management

Problem-solving

Education

Bachelor of Science or related field

MSc. preferred

Job description

Job Summary:

The incumbent will be responsibleto ensure smooth 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, he/she 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 & RESPONSIBILTIES

• 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

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

For interested candidates, please email the detailed resume (with expected pay) to: [e-mail]

Registration No: R1100673

EA No: 99C3289