You are visiting this website from:
Find Talent Find a Job

Analytical Analyst

Back to all Jobs

Job Summary

  • Waterford
  • Permanent
  • 2116
  • Mar 13, 2023
  • Competitive
Job Description

As an Analytical Analyst, you'll play an important role in the day-to-day operation of the Analytical laboratory and supporting site activities.

Position Summary:

The Analytical Analyst reports to the Quality Control Manager and is responsible for analytical method transfers, and method validations/verifications, with minimum supervision. The candidate will be responsible for troubleshooting any OOS/OOT results that are generated in the Analytical Laboratory. The candidate will be responsible for generating and reviewing analytical method validation/transfer protocols and managing laboratory supplies for method transfer/validation. The candidate will help prepare and maintain an inspection-ready status within the laboratory to support regulatory audits. Experience with analysis of biologics including bioassays is highly desirable.

Responsibilities:

  • To perform routine analytical activities as required to support day-to-day laboratory operations.
  • To perform analytical testing.
  • To prepare and execute method transfer protocols and generate reports.
  • To perform method validation/compendial method verification.
  • To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
  • To ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, and safety and environmental guidelines.
  • To identify continuous improvement opportunities.
  • To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement
  • Report any defects or potential hazards.

Qualifications and Skills Required:

  • Minimum of bachelor's degree in pharmaceutical sciences/chemistry or chemical/bioengineering.
  • 5 years' experience in the pharmaceutical industry
  • Experience in analytical method development, method validations, development, optimization, validation, continuous improvement, troubleshooting, tech transfer, operations, risk analyses/FMEA for drug substance (small molecules), drug product
  • Data analysis and presentation skills
  • Problem-solving skills
  • Sterile/Biologics experience required.
  • Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts
  • Demonstrated leadership in a fast-paced company.
  • Team player
  • Ability to communicate clearly and concisely verbally and in writing
  • Working in the Laboratory as and when required.
  • Proficient in Microsoft Office.
  • Professional, proactive demeanor.
  • Strong interpersonal skills.
  • Excellent written and verbal communication skills.

Morgan McKinley is in partnership with Horizon Therapeutics.

broadbean-tracking