Engineer/Scientist I, QC - #145268

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No contact lens 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, must have a good knowledge of basic analytical techniques. Assures compliance to inhouse 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.
• Co-ordinates tech transfer assays and required validations and associated training.
• Performs trouble shooting 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 to the department
• Provides guidance, mentoring and support to new team members
• Performs improvements within atleast one of the QC sub teams.
• QC representative for RCCM sessions and able to advise on required QC testing/support needed to resolve issue
• 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 dept programme, 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 products creation and changes to specifications.
• May be required to perform other related duties as required and/or assigned.
  
  

Education:

Requires a bachelor’s degree within chemistry or science related degree

Experience:

Extensive analytical experience or a related environment is required and can 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 department within the operational department. Customer and external lab communication is also expected within this role

Working Conditions:

Work in conducted in an analytical lab environment. Is required perform raw material sampling, this will involve the movement of boxes and pallets.