Job Description

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 and/or equivalent.
• At least 3 years of experience in Analytical Lab set-up, Analytical equipment qualification and Chemical Analysis.
• Experience in Equipment and Software Lifecycle Management.
• Experience in Software Administration tasks within a regulated laboratory environment.
• Experience in analytical test execution work environment.
• Experience supporting laboratory equipment qualification, calibration, maintenance, and lifecycle activities.
• Knowledge of cGMP requirements and laboratory quality systems.

About Us

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.