Equipment Management Associate - York, UK

Recruiter
Covance
Location
Yorkshire and the Humber
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Join our new lab in York! BioCMC is expanding and we are soon opening the doors to our new 17,000ft2 High quality lab. We are currently recruiting for a Equipment Management Associate.

The BioCMC solutions Division in York will accommodate: Protein Chemistry, ELISA & Cell Based Assay's. The facilities will also include a Sample management Lab, Stability suite, Mass Spec, Cell storage suite, Waste management inc. autoclave and Consumables store.

The lab is based on an attractive 80 acre of parkland on the NAFIC Business Park a few miles north of York and comprises of an On-site Gym, nursery, restaurant & café. There will also be designated parking for Covance employees.

Responsibilities of the position include but are not limited to:

Adhere to and/or complete all equipment documentation. This includes, but is not limited to:

- Standard Operating Procedures (SOP)
- Equipment Training Documentation
- Metrology Specification Requests (MSR)
- Equipment Qualification Documents (e.g., IOPQs, job tasks)
- Other equipment validation documents (e.g., risk assessments, URS, etc.)
- Supplier Approval Request Forms (SARF)
- Total Management System (TMS) Forms
- Work Orders

- Coordinate with in house or vendor maintenance and qualification activities: - Work with Operations to determine appropriate timeframe for maintenance
- Schedule maintenance with Facilities Management (FM)
- Escort vendors during maintenance and qualification activities
- Ensure vendors meet GMP compliance requirements (i.e., approved supplier, training documents obtained, etc.)
- Manage "Do Not Use" tags to ensure instrumentation downtime is minimized

- Where required arrange for the installation and set-up of new equipment.
- Complete GMP quality records to an appropriate standard related to equipment failures and changes: - Deviations
- Change Controls
- CAPAs
- Audit Comments
- Compose documents from concept - Write IQ/OQ/PQ documents for internal execution
- Compose SOPs and Policies as QDMS author

- Serve as the subject matter expert (SME) and main point of contact for equipment / process
- Arrange purchases for GMP EM Team or Operations - Gather quotes / contracts from appropriate service providers
- Execute PO Requisitions / ePro submissions

- Approve documentation completed by other associates with instrument knowledge confidence

Education / Qualifications

The post holder should ideally have a relevant scientific degree and/or an appropriate amount of laboratory experience.

Experience

The post holder should typically have:

- Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
- An understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs.
- Experience with GCP, GMP, Validation, Audits.
- The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.