Scientist, Quality Control (12 Month FTC)

Jazz Pharmaceuticals; Cambridge; Vor Ort; GBP 45.000 - 60.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Retirement plan

Flexible vacation

Zusammenfassung

Jazz Pharmaceuticals is seeking a QC Analyst to analyze and report on test samples (packaging, raw materials, intermediates, finished products and stability) in accordance with cGMP within a fast-paced QA environment.

The role requires hands-on analytical testing using HPLC, GC, TLC, FTIR and UV, with emphasis on documentation, deviation management and timely reporting. Strong attention to detail and collaborative problem-solving are essential.

Qualifikationen

• Typically >3 years relevant post degree work experience in Pharmaceutical/Biotech or related industries.
• Knowledge of cGMP regulations, laboratory instruments and computerised systems.
• Experience with routine analytical instruments (HPLC, GC, TLC, FTIR, UV) and related techniques.

Aufgaben

• Perform analytical testing to SOPs using HPLC, GC, TLC, FTIR, UV and other techniques.
• Provide clear and accurate records of all work performed.
• Record data and notify management of any OOS/OOT/OOE or questionable results.
• Ensure timely reporting and approval of results.
• Identify non-compliances or deviations and notify management.
• Check analytical documentation as appropriate.
• Ensure equipment is calibrated and serviced prior to testing.
• Apply SOPs and test methods to ensure quality of data.

Kenntnisse

HPLC

GC

TLC

FTIR

UV

Laboratory techniques

cGMP knowledge

Documentation

Investigations

CAPA

Root cause analysis

SOP development

LIMS

SampleManager

Empower

Ausbildung

Bachelor’s degree in science

Master’s or PhD preferred

Tools

SampleManager

Empower

Jobbeschreibung

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description

To analyse and report on QC test samples (e.g. packaging items, raw materials, intermediates, finished products and stability samples) in accordance with cGMP.

Essential Functions/Responsibilities

• Perform analytical testing using HPLC, GC, TLC, FTIR, UV and other required techniques in accordance with written procedures
• Provide clear and accurate records of all work performed
• Record data into appropriate records and notify management of any OOS, OOT, OOE or questionable results
• Ensures that all results are reported and approved in a timely manner
• Identifies any non-compliances or deviations and notifies management
• Carries out checking of analytical documentation (where experience and training allows)
• Ensures that all equipment is fully calibrated and serviced prior to testing
• Applies appropriate SOPs and test methods to all testing to ensure compliance and quality of resulting data
• Authoring, reviewing and approving SOPs, protocols, reports and other related documents
• Leading and documenting investigations, identifying the root causes of problems and introducing effective corrective and preventative actions
• Completion of deviations, change controls, CAPA and other QMS documents
• Carries out training of other staff when required/appropriate
• Maintains a clean and tidy work environment, including carrying out housekeeping tasks as assigned
• Maintains stocks of consumables, chemicals, solvents, etc through regular stock checks and re-ordering when required
• Assists with sampling of raw material samples as required
• Actively looks for and implements improvements in productivity and efficiency within own work area
• Works in accordance with the systems in place with regards to health & safety, security and the environment
• Undertakes other activities, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager
• Can sign documents (“pp”) on behalf of other QC personnel (scientists and below) in time of absence, and where experience allows
• Operates in accordance with the company corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence

Required Knowledge, Skills, and Abilities

• Typically >3 years relevant post degree work experience, ideally in the Pharmaceutical, Biotechnology or a related industry
• Knowledge and understanding of cGMP regulations, in particular those relating to laboratory instruments, equipment, and computerised systems
• Experience of using routine analytical instruments (e.g. HPLC, GC, TLC, FTIR, UV etc.) and of routine analytical techniques (titration, pipetting, etc)
• Practical knowledge of the use, maintenance, and troubleshooting of analytical instruments (including HPLC and GC)
• Experience of Pharmacopoeial testing and/or the use of Pharmacopoeias
• Knowledge and experience of LIMS systems (e.g. SampleManager)
• Knowledge and experience of chromatography data systems (e.g. Empower)
• Working knowledge of office IT packages
• Good level of written and verbal communication skills
• Interpersonal skills and professional skills to interact at all levels including managers, contractors, and colleagues
• Excellent attention to detail and ‘concern for quality’

Required/Preferred Education and Licenses

• Bachelor’s degree in science or related discipline
• Post-graduate qualifications (Master’s, PhD) highly regarded

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits