QC Analyst Liverpool, England
Seqirus A CSL Company
Full Time
Liverpool, England
10.56 - 12.04 GBP Today
Job description
The purpose of the QC Incoming and Components Analyst role is to compliantly perform Primary QC inspection, Sampling of raw materials, components laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs) for all primary and secondary packaging components. QC Incoming and components analysts will be required to support release of raw materials and components for use in manufacture. QC incoming and component’s Analysts may also be required to participate in technical and validation studies in support of both departmental and site objectives.
Responsibilities:
- The primary responsibilities of a QC Incoming and Components Analyst is to compliantly perform component 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 raw material and component sampling.
- It is the responsibility of QC Incoming and Components Analysts to communicate their findings as a result of testing/inspections 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 recognized.
- It is the responsibility of QC Incoming and Components Analysts to proactively maintain their own training records, and to only perform tasks that they have confirmed themselves to be compliantly trained in, in accordance with local SOPs
- It is the responsibility of QC Incoming and Components Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.
- It is the responsibility of QC Incoming and Components Analysts, when assigned, to complete critical tasks such as:
- Instrument Maintenance and Calibration
- Sampling booth cleaning and monitoring
- Initiation of deviations
- Initiation, and completion, of CAPAs
- Completion of Change Control actions
- Updates and reviews of SOPs
- Participation in quality risk assessments
- It is the responsibility of QC Incoming and Components Analysts to participate in laboratory administration tasks such as:
- HSE risk assessment completion, review and adherence
- Archiving of laboratory documentation,
- Ordering of materials and consumables
- Maintenance of QC sample and reagent stores
- Ensuring a clean and safe workplace for all associates
Qualification
- Degree in a relevant scientific discipline.
- Experienced in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard.
- 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
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the
benefits
you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL
Seqirus
.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about
Diversity & Inclusion
at CSL Seqirus.
Do work that matters at CSL Seqirus!
Seqirus A CSL Company
www.seqirus.com
Maidenhead, United Kingdom
Paul McKenzie
Less than $1 million (USD)
1001 to 5000 Employees
Subsidiary or Business Segment
Biotech & Pharmaceuticals
2015
