Sterility Assurance Specialist (12 months fixed term)

This is what you will do:

The Sterility Assurance Specialist will support implementation and execution of activities for the microbial control of manufacturing including execution of quality risk management and on-site training.

An understanding of manufacturing processes for biotechnological product manufacturing (upstream downstream and aseptic filling) is required.

The position requires effective cross-functional working relationships with Operations Technical Services Engineering Facilities Quality Assurance and Quality Control groups.

You will be responsible for:

Support the Sterility Assurance/Contamination control programs in AAMF for all manufacturing processes.

Co-ordinate and execute training for Alexion personnel in basic microbiology contamination control and aseptic techniques.

Provide on-floor contamination control support and troubleshooting.

Monitor microbiological data of classified areas/ utilities to detect trends and perform analysis of data generated by other site departments and external laboratories.

Identify and lead process improvements in aseptic practices and contamination control. Progress changes using change control management system as required.

Adherence to highest standards for Compliance (Quality and Safety) implement corporate standards and provide technical support during audits.

Ensure compliance with site EHS policy cGMP and other business regulations.

Perform other tasks as identified by the Sterility Assurance Lead.

You will need to have:

Bachelors degree in Science.

Experience working in cGMP environment such as biotech. pharmaceutical or bio-pharmaceutical manufacturing.

Proven experience writing GMP documents i.e. SOPs protocols summary reports.

Self-motivated detail orientated with excellent organizational skills.

The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

Bachelors degree in Microbiology or Biology.

2-3 years of Microbiology or Quality Assurance experience in a biotech. pharmaceutical or bio-pharmaceutical manufacturing environment.

High level of proficiency in MS Office software including: Word Excel Outlook Visio and PowerPoint.

Experience with Quality Risk Management tools and techniques.

Ability to analyse data and think objectively.

Excellent communication and interpersonal skills.

Date Posted

Closing Date