Chemist - P2 jobs at Boston Scientific in Malaysia

Purpose Statement:

Job Responsibilities:

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment and qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Review and approval of Laboratory results and documentation, as required the trending and charting of data.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Provide analytical support to process validations.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Coordinate Preventive Maintenance and Calibration activities for equipment and ensure no event of Calibration/PM overdue.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Manage/handle lifecycle management of an equipment, i.e., Procurement, Commissioning, Qualification Maintenance, Calibration, troubleshooting, availability of contingency equipment and Retirement of the equipment and software.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Routinely inspect the Equipment for proper use and care by the analyst.
• Initiate and own NCEP/CAPA as per required.
• Review and approve laboratory data packs to confirm if they meet the quality requirements.

• Works as a member of the Penang Analytical Laboratory (PAL) Team to complete all required analysis in a timely manner.
• Capable of operating analytical instruments (HPLC, GCFID/MS, Karl Fischer, Dissolution Apparatus, UV-Vis and FTIR)
• Capable of preparing buffers, mobile phase, reagents and media needed for analysis
• Provide testing evaluation of raw materials, intermediates, and finished products samples based on specifications
• Perform investigations into suspected analytical lab testing results i.e. OOS, OOT, atypical data etc.
• Interprets and applies department policies and procedures and applicable laws, rules, and regulations
• Understand and precisely follows Standard Operating Procedures, global methods, local methods and published standard or compendia methods USP, AOCS, ASTM
• Render appropriate dispositions for all sample lots with test results outside specified limits
• Use analytical and problem solving skills to solve manufacturing issues/ problems related to Analytical Chemistry Science and contaminations.
• Maintain calibration of specific laboratory equipment as outlined in the calibration procedure
• Troubleshooting of Analytical equipment and associated Lab software
• Perform Analytical equipment qualifications, Analytical method validation/ verification activities
• Maintain standardization and replenishment of all laboratory volumetric solutions and reagents
• Ensure all samples no longer needed are boxed and properly identified for disposal

• BSc or higher in chemistry or relevant scientific discipline
• Basic computer skills such as Word, Excel
• Ability to follow all methods and procedures in strict compliance with FDA cGLP guidelines
• Must be comfortable working on individual projects leading/participating in a team across various functions to deliver results on tight timelines
• Expertise and practical laboratory experience
• At least 1-2 years of experience with HPLC/ GCFID/MS along with other analytical instrumentation
• Excellent written, oral, and visual communication skills to communicate effectively with all levels and teams of the organization

Purpose Statement:

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

Job Responsibilities:

• Primary Commitment to patient safety and product quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include analysis of raw material, in-process, finished product, Stability and process validation samples.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Review of all laboratory Quality Systems to ensure compliance with cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Initiate and own NCEP/CAPA as per required.
• Conduct initial reviews of laboratory data packs to ensure accuracy and completeness.

Job Requirements:

• Candidate must possess at least a Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• At least 2-5 years of experience in Analytical Lab set-up, Analytical equipment qualification and Chemical Analysis.
• Required skill(s): FTIR, HPLC, GCMS, GCFID Analytical Analysis and equipment qualifications.
• Experience in LIMS set-up and empower software is preferable.
• Knowledge of GMP, GLP, ISO13485 will be added value.
• Required language(s): English

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• Purpose Statement:

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

• Job Responsibilities:

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment and qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Review and approval of Laboratory results and documentation, as required the trending and charting of data.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Provide analytical support to process validations.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Coordinate Preventive Maintenance and Calibration activities for equipment and ensure no event of Calibration/PM overdue.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Manage/handle lifecycle management of an equipment, i.e., Procurement, Commissioning, Qualification Maintenance, Calibration, troubleshooting, availability of contingency equipment and Retirement of the equipment and software.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Routinely inspect the Equipment for proper use and care by the analyst.
• Initiate and own NCEP/CAPA as per required.
• Review and approve laboratory data packs to confirm if they meet the quality requirements.

• Job Requirements:
• Candidate must possess at least a Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• At least 3-5 years of experience in Analytical Lab set-up, Analytical equipment qualification and Chemical Analysis.
• Required skill(s): FTIR, HPLC, GCMS, GCFID Analytical Analysis and equipment qualifications.
• Experience in LIMS set-up and empower software is preferable.
• Knowledge of GMP, GLP, ISO13485 will be added value.
• Required language(s): English