Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) and Safety Standards. No contact lens allowed; prescriptive glasses will be provided. Standing for the full shift.
Job Description
Position Objective:
Responsible for carrying out finished goods and raw material sampling and testing within an ISO-accredited laboratory environment. Essential functions include pharmacopeia testing, UPLC, and ICPMS. Must have a good knowledge of basic analytical techniques. Ensures compliance with in-house and external specifications and standards. Actively leads data collection, trend analysis, investigation, and improvement processes.
Essential Functions:
1. Manage lab schedule, direct staff to required tasks, and verify output.
2. Coordinate tech transfer assays, validations, and related training.
3. Perform troubleshooting and equipment maintenance on UPLC, ICPMS, and other analyses to resolve complex issues, supporting the team.
4. Execute routine equipment and assay validations.
5. Lead projects for introducing new assets into the department.
6. Provide guidance, mentoring, and support to new team members.
7. Implement improvements within at least one QC sub-team.
8. Represent QC in RCCM sessions and advise on QC testing/support needed to resolve issues.
9. Attend customer calls and provide technical guidance.
10. Perform audit tours of the areas worked in.
11. Lead departmental programs such as stability, environmental monitoring, and raw material batch testing.
12. Cross-train team members; coach or mentor junior team members.
13. Review and approve new product creation and changes to specifications.
14. Perform other related duties as required or assigned.
Education:
Bachelor’s degree in chemistry or a related science field.
Experience:
Extensive analytical experience or in a related environment, demonstrating excellent knowledge of scientific principles.
Strong oral and written communication skills, with the ability to work effectively in a cross-functional team and interact with all company levels. Effective collaboration with internal and external development teams is essential.
Contacts:
Extensive liaising with other departments within operations. Customer and external lab communication is also expected.
Working Conditions:
Work is conducted in an analytical lab environment. The role involves raw material sampling, which includes moving boxes and pallets.
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