Quality Control Engineer/Scientist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Objective:

Responsible for carrying out finished goods testing within an ISO accredited laboratory environment. This role is a unique opportunity to cross train between the analytical chemistry and microbiology departments at the Inchinnan site, Essential functions include, Pharmacopeia testing, UPLC, ICPMS, Environmental Monitoring, Sterility, Bioburden, PCR testing. Candidate must have a good knowledge of basic analytical and aseptic 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 troubleshooting and equipment maintenance to resolve complex issues
• Executes routine equipment and assay validations.
• Project manages introduction of new assets within to the department
• Provides guidance, mentoring and support to new team members
• Performs 5S and Gemba audits and leads 5S improvements.
• QC representative for RCCM sessions and able to advise on required QC testing/support needed to resolve issue
• May attend customer calls and provide technical guidance.
• May lead dept program e.g stability, Environmental Monitoring.
• Cross trains team members; may coach / mentor junior team members
• Review and approve new products creation and changes to specifications.

Education:
Requires a bachelor’s degree within a Chemistry or Microbiology discipline.

Experience:

Extensive analytical / microbiology experience or experience in a related environment is required.

Strong oral and written communication skills with a demonstrated ability to work in a cross functional team environment.
Effective communication skills and the ability to collaborate with internal and external stakeholders is 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 is conducted in an laboratory environment. Manual handling Is required to perform raw material sampling and stock up, this will involve the movement of boxes and pallets.

Replace this text with the Job Requisition job description.