Chemist - P1

Boston Scientific; George Town; On-site; MYR 40,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Chemist, where your expertise in analytical testing and compliance will play a crucial role in ensuring patient safety and product quality. In this dynamic position, you will engage in method development, validation, and the analysis of critical samples, all while adhering to stringent cGMP standards. With opportunities to participate in continuous improvement projects and regulatory audits, your contributions will directly impact the quality of innovative medical solutions. This role not only promises professional growth but also allows you to make a meaningful difference in patient health worldwide.

Qualifications

• 2-5 years of experience in analytical laboratory setup and chemical analysis.
• Proficient in laboratory software applications and equipment qualification.

Responsibilities

• Conduct analytical testing on various samples ensuring compliance with cGMP.
• Analyze raw materials and maintain laboratory quality systems.

Skills

FTIR

HPLC

GCMS

GCFID analysis

Analytical testing

cGMP compliance

Education

Bachelor's Degree in Chemistry

Bachelor's Degree in Analytical Chemistry

Bachelor's Degree in Applied Science

Bachelor's Degree in Life Science

Tools

LIMS

Waters Empower

Job description

Purpose Statement

The purpose of the Chemist role is to conduct analytical testing on commercial, stability, and non-routine samples. They participate in test method development, validation, and technical transfers as required. They are responsible for ensuring all testing complies with cGMP standards.

Job Responsibilities

1. Primary commitment to patient safety and product quality.
2. Understand and comply with all regulations governing the quality systems.
3. Deliver key Quality and Performance Objectives; maintain laboratory scorecards and trackers.
4. Ensure compliance with mandatory training requirements; keep training records up to date and compliant with cGMP.
5. Analyze raw materials, in-process, finished products, stability, and process validation samples as applicable.
6. Complete documentation related to testing, method development, validation, and equipment qualification in a timely manner.
7. Ensure all analytical testing is conducted according to the Quality System.
8. Perform equipment qualification following USP Analytical Instrument Qualification and GAMP5 guidelines.
9. Perform in-house calibration, preventive maintenance, temperature mapping, and software maintenance activities.
10. Review laboratory Quality Systems for cGMP compliance.
11. Participate in regulatory, internal, and vendor audit programs as required.
12. Assist with additional duties as directed by Lab Management.
13. Proficient in laboratory software applications such as LIMS and Waters Empower; develop, configure, and validate software in line with industry standards.
14. Create, review, and approve change requests.
15. Manage laboratory inventory and supplies, including procurement.
16. Participate in CAPA, continuous improvement projects, and other team initiatives.
17. Assist in OOS investigations, identifying causes and corrective actions.
18. Initiate and own NCEP/CAPA processes as required.
19. Review laboratory data packs for accuracy and completeness.

Job Requirements

• Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science, or Life Science.
• 2-5 years of experience in analytical laboratory setup, equipment qualification, and chemical analysis.
• Skills in FTIR, HPLC, GCMS, GCFID analysis, and equipment qualification.
• Experience with LIMS setup and Empower software is preferred.
• Knowledge of GMP, GLP, ISO13485 is advantageous.
• Proficiency in English.

About Us

Boston Scientific has been a global leader in medical technology for over 40 years. Our mission is to transform lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide.