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QC Analyst 2047

  • Job reference: 931346
  • Location: Liverpool, Merseyside
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 09/07/2020

Orion Group are recruiting a QC Analyst on behalf of our Multinational Pharmaceutical Client on an initial 12 month contract.

QC Analyst

Job Summary

The purpose of the QC Analyst role is to compliantly perform QC laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs). Analysis is performed on in-process, intermediate and finished vaccine products, raw materials, components and utilities samples. QC Analysts are also required to participate in technical and validation studies in support of both departmental and site objectives.

Accountability Description

  1. The primary responsibility of a QC Analyst is to compliantly perform laboratory testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as defined in the EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.

In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and sampling.

It is the responsibility of QC Analysts to communicate their findings as a result of testing promptly, to the QC Analytical leadership team (Team Coordinators and Manager). Specifically, it is expected that deviations (either out of specification results or compliance gaps) are highlighted to a leadership team member immediately as they are recognised. (70%)

  1. It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:

  • Instrument Maintenance and Calibration
  • Sampling booth cleaning and monitoring
  • Reagent and Standard Qualification
  • Initiation of deviations
  • Initiation, and completion, of CAPAs
  • Completion of Change Control actions
  • Updates and reviews of SOPs
  • Participation in quality risk assessments (20%)

  1. It is the responsibility of QC Analysts to participate in laboratory administration tasks such as:

  • HSE risk assessment completion, review and adherence
  • Archiving of laboratory documentation,
  • Ordering of reagents and consumables
  • Maintenance of QC sample and reagent stores
  • Ensuring a clean and safe workplace for all associates (10%)

Skills & Competencies

QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:

  • Have experience in QC testing techniques appropriate to their role
  • Have experience in cGMP application
  • Have an awareness of the requirements for equipment and method validation
  • Have awareness of root cause analysis
  • Be computer literate and be able to demonstrate an understanding of electronic systems

Education

Minimum Education Requirements

Minimum educational level necessary to perform the job (High School diploma, Assoc Degree, Bachelor's Degree, Masters, PhD)

Experience Required

QC Analysts must be have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.