Engineer/Scientist I, QC

Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, no contact lenses allowed; prescriptive glasses will be provided, standing for full shift.

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, with a good knowledge of basic analytical techniques. Assures compliance to in-house and/or external specifications and standards. Actively leads the data collection, trend analysis, investigation, and improvements processes.

Essential Functions:

• Able to manage lab schedule and direct staff to required tasks for completion and verify output.
• Coordinates tech transfer assays and required validations and associated training.
• Performs troubleshooting and equipment maintenance to resolve complex issues on the UPLC and ICPMS, including all other analysis and tasks performed, supporting the team.
• Executes routine equipment and assay validations.
• Project leads introduction of new assets within the department.
• Provides guidance, mentoring, and support to new team members.
• Performs improvements within at least one of the QC sub-teams.
• QC representative for RCCM sessions and able to advise on required QC testing/support needed to resolve issues.
• Will be required to attend customer calls and provide technical guidance.
• Will be required to perform audit tours of the areas worked in.
• May lead department programmes, e.g., stability, environmental monitoring, and raw material 3 batch testing.
• Cross trains team members; may coach/mentor junior team members.
• Review and approve new product creation and changes to specifications.
• May be required to perform other related duties as required and/or assigned.

Education: Requires a bachelor’s degree in chemistry or a science-related degree.

Experience: Extensive analytical experience or a related environment is required and must demonstrate excellent working knowledge of scientific principles. Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels of the company. Effective communication skills and the ability to collaborate with internal and external development team members are essential.

Contacts: Will liaise extensively with all other departments within the operational department. Customer and external lab communication is also expected within this role.

Working Conditions: Work is conducted in an analytical lab environment. Is required to perform raw material sampling, which will involve the movement of boxes and pallets.