Engineer/Scientist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Summary:

Responsible for carrying out Finished good and Raw material sampling and testing within an ISO accredited laboratory environment. Essential functions include, Pharmacopoeia testing, UPLC, ICPMS analysis and must have a good knowledge of basic and sophisticated analytical techniques. Assures compliance to in-house and/or external specifications and standards.

Actively leads the data collection, trend analysis, investigation, method development and improvements processes.

Responsibilities:

• Performance and subject matter expert in Analytical techniques related to finished goods release testing in accordance with standard operating procedures in a timely and efficient manner.

• Responsible for leading and troubleshooting technical and instrumental queries across the analytical chemistry department.

• Will be the first point of contact for Analytical queries and technical enquiries or escalations within the department.

• Pro-actively works closely with Production, Technical and Manufacturing to resolve quality related issues arising from customer complaints/concerns and internal Incidents. Responsible for the facilitation of investigation and resolution of related quality issues.

• Identify and implement opportunities across the quality department and operational facility.

• Able to be independently decisive where appropriate and work on own initiative.

• Perform statistical analysis to review trends in data and drive improvement programmes.

• Exercise considerable latitude in resolving technical objectives and solutions to complex problems

• Constantly strives to enhance efficiency in procedures and processes without compromise in quality

• May be required to perform other related duties as the need arises.

Minimum Requirements/Qualifications:

Education:

Requires a bachelor's degree within a Chemistry field.

Experience:

Extensive analytical experience, and an experience working in a related environment is required, can demonstrate solid understanding of scientific principles.

Experience operating and troubleshooting HPLC and ICP-MS/OES systems, Method development and Validation Experience also crucial.

Strong oral and written communication skills with a demonstrated ability to work in a multi-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.

Strong understanding of ISO 13485 and Quality management systems

Contacts:

Will collaborate closely 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, May be required to perform raw material and WFI sampling, this will involve the movement of boxes and pallets