Connecting to LinkedIn...

QC Analyst – Lab Services - Contract

Job Title: QC Analyst – Lab Services - Contract
Contract Type: Contract
Location: Cork
Industry:
REF: 98397
Job Published: 3 months ago

Job Description

All applicants must have a working visa for Ireland for this contract role

Contact: Niamh Hlubek
Email: recruit@hero.ie
Telephone: 086 8168298

QC Analyst – Lab Services - Contract

Our client, a medical device company in Cork are currently looking to recruit a QC Analyst for their site on a contract basis.

Description:
  • The QC Analyst – Laboratory Services will be responsible for the following.
  • Developing and qualifying the electronic data management processes for the QC team
  • Administrating and maintaining Laboratory electronic systems
  • You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
  • Strong analytical skills
  • Excellent communication, written and oral
  • Acute attention to detail
  • Adaptable and flexible
  • Excellent team player with strong customer focus
  • Knowledgeable of FDA/EMEA regulatory requirements
 
  • Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro
  • Providing day to day operational & training support for laboratory systems
  • Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates.
  • Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates
  • Interacts and represents the Cork site on Global COEs related to laboratory systems.
  • Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines
  • Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
  • Anticipates and plans for future requirements in the area.
  • Deals with events/ deviations in an accurate and timely manner.
  • Identifies opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
  • Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
  • Deputizes for the supervisor and other ream members as appropriate.
  • Collaborates across multiple lab groups and with other Janssen sites
  • BSc Hons (or Higher) in a Science or related discipline.
  • A minimum of 2 years’ experience in a similar role within a laboratory environment
  • Excellent social and communication skills
  • Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies
  • Self-driven and keeps up to date with regulatory, technical developments within the industry.
  • Focus on patients and customers at all times.

For further information on this QC Analyst role in Cork please contact Niamh Hlubek 086 8168298 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval