The Quality control department ensures that all aspects of the manufacture of products are performed in a controlled manner and meet commitments to regulatory bodies and the requirements of current Good Manufacturing Practice. The laboratory teams work as part of site value streams alongside the business centres to ensure that manufactured products are compliant and fit for purpose.
To ensure that all microbiological and chemistry testing is carried out as required by the GSK specification on all raw materials, bulk intermediates and finished products.
· Carry out testing as a highly skilled analyst of all laboratory samples for raw materials, chemistry bulk product or microbiological testing to requirements of methods, pharmacopoeias, GSK specifications or protocols following ALCOA principles (attributable, legible, contemporaneous, original and accurate).
· Maintain a specialism in either microbiology or chemistry to ensure the minimum team qualification capability is maintained. Identify needs for continuous professional development to maintain qualified skills.
· Executes the daily testing and verification activities for the laboratory as per the plan provided by the QC Lead Analyst or QC Team Manager to meet the site 6-day end-to-end testing targets. Promptly escalate issues as they arise and propose viable solutions to recover activities and return to plan.
· Prepares and checks analytical data accurately, upholding strong standards of data integrity and driving continuous improvement to simplify and improve working practices.
· Takes a supporting role in verifying the quality and accuracy of analytical results to determines if the material meets pre-defined acceptance criteria. Ensures valid, precise and accurate results are released to customers.
· Supports laboratory activities where necessary by preparing buffer solutions and reagents, sampling bulk tanker deliveries or calibration checks to enable smooth continuity of analyst tasks.
· Is responsible for identifying improvement activities to ensure safety of self and others within the laboratory.
· Participates in projects to improve EHS, Quality, Supply or Cost in the laboratory as directed by the QC Lead Analyst or QC Team Manager and identifies and highlights further opportunities for improvement.
· Checks all equipment before use to ensure it is calibrated, validated and fit for use. Checks all media, reagents and standards before use to confirm within expiry date and correctly prepared. Deficiencies are escalated and resolved promptly.
· Responsible for own training and development. Maintains up to date training records and performance and development plans. Identifies requirements for further training as required to support areas of responsibility.
· Recognise when a deviation has occurred and escalate following relevant site process. Actively and constructively participate in investigations, ensuring transparency on all errors.
· Use of SAP as a LIMS system to record and release testing, control material availability and record investigations and comments.
· Carry out sampling of critical site processes including tankers, water systems and other environmental monitoring sampling points.
· Authors investigations (e.g. LIRs, EHS, EMIs and deviations). Accurately and promptly records the defect and escalates to QC Lead Analyst and QC Team Manager, ensures all hypothesis and retesting is appropriately authorized before generating additional results against batches of material.
· Ensures documents associated with own areas of responsibility, such as equipment records, logbooks and laboratory paperwork are current and audit ready at all times. All documents and analytical reports are accurate, clearly laid-out, legible and recorded contemporaneously (at the time of the task). Strives for documentation complexity reduction, automation and paperless ways of working.
· Is responsible for ensuring sustained high standards of maintenance of 5S standards and equipment cleanliness.
· Manage stocks of consumables, chemicals, media and essential testing requirements, ensuring Kanbans are adhered to and maintained, and orders placed to maintain levels.
· Participates and takes a proactive role in daily team meetings. Brings updates on own work and raises issues as they arise before they impact laboratory performance where possible.
· Assumes additional responsibility in the absence of other team members.
· Always contributes positively to team or department. Shares learnings and best practices, seeks and shares feedback. Understands how own objectives and behaviours will contribute to the team achieving its goals.
· Has excellent planning and organizational skills, able to robustly plan and organize own work according to the pre-defined schedule.
· Supports and rotates leadership of the daily tiered accountability process.
· Identifies proactively when behind against scheduled workload and acts to rectify.
· Has a keen eye for detail and is readily able to identify procedural or GMP errors.
· Strives to ensure own work is right first time, and supports initiatives and identifies opportunities to reduce analytical errors across the laboratories.
· Embraces own errors as an opportunity for improvement and shares learnings.
· Is capable of presenting information clearly to own teams and across quality using various media. Has good written and verbal communication skills.
· Leads by example in all aspects of the role.
· Acts as a champion for change, advocating the implementation of new initiatives from continuous improvement projects.
· Demonstrates the key capabilities, behaviours and values as set out in the GSK Leadership profile for “Leading Self”.
1. Minimum Level of Education
BSc degree in Science
Area of Specialisation
Chemistry or Microbiology
Why is this Level of Education Required?
The analyst is the primary responsible person for providing accurate and robust testing data to support release of product and raw materials. A high level of scientific understanding is critical to rapid support and problem solving.
Minimum Level of Job-Related Experience required
Requires proficient knowledge of either a chromatography technique, UV or IR spectroscopy or microbiology (pour plating and counting, environmental monitoring and filtration, identification).
Minimum of 6 months experience in a laboratory setting is highly preferred.
Why is this Level of Experience Required?
Although not mandatory, this provides a robust starting point for GSK training to rapidly bring the QC Analyst to an operational level.
C. Other Job-Related Skills/Background
List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.
· Aware of basic GMP principles and how they protect the consumer.
· Is computer literate, competent in use of Microsoft packages, SAP and corporate IT systems.
D. Organisation Chart
Insert the job name, the name of the job role they report to and the name of their team if they manage people. e.g. Organisation chart for First Line Leader could be: Reports to Operations Manager – First Line Leader – Manages Filling and Packing Team.
QC Analyst, reporting to QC Team Manager, no direct management responsibility.