ACME
Sterility Assurance Specialist
Sterility Assurance Specialist
Location: Beeston, Leeds
Working mode: On-site, Mon-Fri
Duration: 12 months
Hours: 37 hours per week
Pay rate range: Competitive hourly rate (PAYE and Umbrella options available)
The purpose of this role is to support the Sterility Assurance and Microbiology team in the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.
roles and responsibilities
To support the microbial assurance aspects of the Quality System.
To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate.
To co-ordinate use of all microbial services.
To support the review and development of procedures for all microbial assurance activities.
To carry out regular internal auditing of all clean room facilities and other areas.
To implement the GMP training program for clean room and other appropriate staff.
To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required.
To support the release of sterile products.
To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate.
To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures.
To adhere to the Company’s procedures as detailed in the SOP manual.
Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring.
To support specific projects as allocated by the International Sterility Assurance Manager.
All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
how to succeed
High Attention to Detail
Pro-active approach to Work
High Standards
Flexible
Excellent Communication Skills
Influencing Skills (Written & Oral)
Team Player
High level of Numeracy
Highly Computer Literate
Planner & Organiser
Bright
Degree level qualification grade 2:1 or higher, in one of the following areas:
Medical Engineering
Mechanical Engineering
Biomedical Sciences
Microbiology
BioEngineering
Post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
Familiarity with microbiological aspects of GMP regarding sterile medical devices.
Experience of conducting GMP audits, internal and relevant external audits.
benefits
This role offers a very competitive hourly rate. This contract will run for a 12 months and has a strong chance of extension.