Senior Analyst (Bioscience, Microbiology, Office hours, 1 year contract) - #1110620

Location: East

Working Hours: Mon – Fri, office hours

Duration: 1 year contract

Salary: Up to $5,000 per month

Job Description:

• 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

Requirements:

• 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)

• Singaporeans only