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:
* Manage lab schedule and direct staff to required tasks for completion, verifying output.
* Coordinate tech transfer assays, required validations, and associated training.
* Perform troubleshooting and equipment maintenance to resolve complex issues on UPLC and ICPMS, including other analyses and tasks supporting the team.
* Execute routine equipment and assay validations.
* Lead projects for the introduction of new assets within the department.
* Provide guidance, mentoring, and support to new team members.
* Implement improvements within at least one of the QC sub-teams.
* Represent QC in RCCM sessions and advise on QC testing/support needed to resolve issues.
* Attend customer calls and provide technical guidance as required.
* Perform audit tours of the areas worked in.
* Lead department programs such as stability testing, environmental monitoring, and raw material batch testing.
* Cross-train team members; coach and mentor junior team members.
* Review and approve new product creation and changes to specifications.
* Perform other related duties as required and/or assigned.
Education:
Bachelor’s degree in chemistry or a related science field is required.
Experience:
Extensive analytical experience or experience in a related environment is required, with 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. Ability to collaborate with internal and external development teams is essential.
Contacts:
Extensive liaising with other departments within the operational area. Customer and external lab communication are also expected.
Working Conditions:
Work is conducted in an analytical lab environment. The role involves raw material sampling, which may require moving boxes and pallets.
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