Quality Analyst

Kinetic PLC; Preston on the Hill; On-site; GBP 31,000; Full time

Job summary

A leading international pharmaceutical company in the Runcorn area is seeking a Quality Analyst to ensure the sterility and quality of the finished products through microbiological testing. Candidates should have a relevant degree in microbiology or biological sciences, with strong attention to detail and excellent communication skills. This role includes shifts and offers competitive compensation and benefits, including annual leave and shift allowances.

Benefits

25 days annual leave (pro rata)

19% shift allowance

Qualifications

• Strong understanding of the need for quality.
• Organised and capable of prioritising tasks.

Responsibilities

• Perform environmental monitoring in clean rooms.
• Undertake microbiological testing of components.
• Provide technical support for contamination control.

Skills

Excellent written and oral communication skills

Strong attention to detail

Computer literate

Customer focus

Teamwork

Pharmaceutical knowledge and experience

Education

Degree or HNC in microbiology/biological sciences

Tools

Word

Excel

Job description

Kinetic Recruitment is currently looking for a Quality Analyst to work for an international pharmaceutical company based within the Runcorn area.

Annual salary: £30,060. 18 months from start, 25 days annual leave (pro rata) plus bank holidays, 19% shift allowance applicable.

Shift pattern: 2-week shift rotation – Monday, Tuesday, Friday, Saturday, Sunday, Wednesday and Thursday – 06:00am to 18:00pm.

Purpose of Role

To provide data through microbiological testing regimes, from which confidence in the sterility of the finished product can be founded and to provide technical support to production on microbiological/hygiene and contamination control issues.

Key Results Areas

• Perform environmental monitoring within Grade B-D clean rooms and filling machines at the appropriate frequency.
• Undertake testing of key components – in-process samples, raw materials and finished product – using techniques such as T.V.A.C., bacterial endotoxin and sterility testing. All tests are completed using good aseptic technique; results entered into the microbiology database and trended where necessary. Anomalous results are communicated to the team leader.
• Undertake testing of utility services (water for injection, compressed air, room particle counting).
• Support validation work of the above techniques when required.
• Meet departmental KPIs and monitor high RFT (right-first-time) records.
• Conduct bacterial identification, control of type cultures and in-house media QC, media preparation and use of the autoclave.
• Complete documentation in real time, compile batch summary reports ready for batch release, compile quality-department reports to solve microbiological issues, and complete performance-qualification documentation to required standard. Maintain training records and progress training in line with business needs.
• Provide advice to the manufacturing department on microbial, hygiene and contamination control. Deliver feedback to other departments.
• Consistently demonstrate required behaviours such as teamwork and attention to detail.

Areas of Impact Affecting the Job

• Testing on intermediate and finished products to support each batch manufactured, including microbiological testing and reading of media studies completed on filling machines.
• All necessary testing, directly and indirectly associated with each batch, is completed within the target time – 100% sterility test pass rate with no false positives.
• Environmental monitoring in all clean areas when in use; laboratory testing completed in real time.
• Work within a team to ensure tasks are completed in a fast-paced laboratory, coordinated by seniors and team leader, supporting sterility assurance of products and medicines.
• Plan, organise and control day-to-day tasks under the technician’s responsibility, as directed by senior microbiology technicians or team leader. Report delays or incomplete tasks directly to seniors.

Knowledge, Skills and Abilities

• Excellent written and oral communication skills at all levels.
• Strong attention to detail, thorough understanding of the need for quality.
• Computer literate with familiarity with Word, Excel and similar programs.
• Organised, capable of prioritising when priorities change.
• Customer focus, teamwork, initiative and maximising performance.
• Preferably pharmaceutical knowledge and experience.
• A degree qualified or HNC in microbiology/biological sciences with lab experience.

If you feel that you have what we need, please call Sophie or email your up-to-date CV to the contact details provided in the job posting.