Microbiology Lab Lead – Quality & Compliance

Boston Scientific; George Town; On-site; MYR 66,960 - 100,440; Full time

Job summary

Boston Scientific in Penang, Malaysia, is seeking a Microbiology Laboratory professional to uphold patient safety and product quality by conducting tests and reviewing data per approved procedures. The role supports internal and external audits and provides guidance to junior lab staff.

The successful candidate will have a Bachelor in a related science field, at least 3 years in a regulated manufacturing lab, and strong knowledge of microbiology and quality systems.

Qualifications

• Bachelor degree in Microbiology, Biotechnology, Chemical, Industrial Science or related field.
• Minimum 3 years of relevant working experience.
• Knowledge of microbiology principles, laboratory operations, and quality systems.
• Experience in a regulated manufacturing environment is a plus.
• Ability to work independently and collaboratively in cross-functional teams.

Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025).
• Conduct testing according to written procedures.
• Review all data and associated data reports for conformance to specifications.
• Ensure all training is completed per Laboratory Training Program 92048659.
• Ensure notebooks/logbooks/Datasheets are completed and reviewed timely.
• Record all information and raw data on designated forms or logbooks and/or via systems.
• Assist manufacturing/operations/quality personnel in solving quality-related problems.
• Ensure NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I & II roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross functional project teams.
• Designee for Senior Microbiologist overseeing day-to-day operation of the Microbiology laboratory.
• Coordinate and/or perform method validations of new products.
• Assist in implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification; write related protocols/reports.
• Documentation control – update documentation to ensure documents are controlled as required.
• Coordinate and train to ensure compliance to mandatory training requirements.
• Communicate concerns about work process regarding environmental impact, health or safety to Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Perform and assist with additional duties as directed by the Senior Microbiologist.

Skills

Microbiological Laboratory Skills

Analytical Skills

Knowledge in Microbiology Medical Dev

Problem Solving Skills

Data review and interpretation

Technical investigation and Troublesh

Communication and cross-functionalColl

cGMP & regulatory knowledge

Test method validation experience

Education

Bachelor of Science in Microbiology, Biotechnology, Chemical, Industrial Science or related field

Job description

Boston Scientific in Penang, Malaysia, is seeking a Microbiology Laboratory professional to uphold patient safety and product quality by conducting tests and reviewing data per approved procedures. The role supports internal and external audits and provides guidance to junior lab staff.

The successful candidate will have a Bachelor in a related science field, at least 3 years in a regulated manufacturing lab, and strong knowledge of microbiology and quality systems.