Chemist - P2

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

Job summary

Join a leading global medical technology firm as a Chemist II, where your expertise in analytical testing will contribute to innovative medical solutions. This role emphasizes patient safety and product quality, requiring proficiency in test method development and compliance with stringent quality standards. Engage in a collaborative environment that values continuous improvement and offers opportunities for professional growth. Your contributions will directly impact patient health and enhance the quality of life for individuals worldwide. Be part of a mission-driven team dedicated to transforming lives through cutting-edge medical advancements.

Qualifications

• 3-5 years of experience in analytical lab setup and chemical analysis.
• Proficient in test method development and validation.

Responsibilities

• Conduct analytical testing on commercial and stability samples.
• Ensure compliance with cGMP standards in all testing.

Skills

FTIR

HPLC

GCMS

GCFID analysis

Equipment qualification

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 II role is to conduct analytical testing on commercial, stability, and non-routine samples. The role also involves participating in test method development, validation, and technical transfers as required. The Chemist II is responsible for ensuring all testing is performed in accordance with cGMP standards.

Job Responsibilities:

1. Maintain a primary commitment to patient safety and product quality.
2. Understand and comply with all regulations governing 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. Responsibilities may include test method development and validation, raw material testing, in-process testing, finished product testing, and stability testing.
6. Complete documentation related to testing, method development, validation, and equipment qualification in a timely manner.
7. Ensure all analytical testing aligns with the Quality System requirements.
8. Perform equipment qualification following USP Analytical Instrument Qualification and GAMP5 standards as required.
9. Review laboratory Quality Systems to ensure cGMP compliance.
10. Participate in regulatory, internal audits, and vendor audit programs as required.
11. Provide training, technical guidance, troubleshooting, and review of training records for laboratory staff.
12. Review and approve laboratory results and documentation; trend and chart data as needed.
13. Assist with additional duties as directed by Lab Management.
14. Provide analytical support for process validations.
15. Proficient in laboratory software applications such as LIMS and Waters Empower; develop, configure, and validate software in line with industry standards.
16. Create, review, and approve change requests.
17. Manage laboratory inventory and supplies, including procurement.
18. Participate in projects like LBP, VIP, Quality Catch, CAPA, and continuous improvement teams.
19. Coordinate preventive maintenance and calibration activities for laboratory equipment, ensuring no overdue events.
20. Participate in OOS investigations, identifying causes and corrective actions.
21. Manage lifecycle of equipment including procurement, qualification, maintenance, calibration, troubleshooting, and retirement.
22. Perform in-house calibration, preventive maintenance, temperature mapping, and software maintenance activities.
23. Inspect equipment routinely for proper use and care.
24. Initiate and own NCEP/CAPA processes as required.
25. Review and approve laboratory data packs to ensure quality standards are met.

Job Requirements:

• Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science, or Life Science.
• 3-5 years of experience in analytical lab setup, equipment qualification, and chemical analysis.
• Skills required: FTIR, HPLC, GCMS, GCFID analysis, and equipment qualification.
• Experience with LIMS setup and Empower software is preferred.
• Knowledge of GMP, GLP, ISO13485 is advantageous.
• Language requirement: English.

About Us

As a global medical technology leader for over 40 years, Boston Scientific's mission is to transform lives through innovative medical solutions that improve patient health. Join us to make a meaningful difference worldwide.