Why work for this company?
Our client discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.
- 65+ years of experience in animal health
- Nearly $6 billion annual revenues
- 25 manufacturing sites around the world
- 10,000 employees worldwide of which 1,100 employees are committed to R&D
- Job Description
The QC Analytical Chemist reports to the Quality Control Lead, and will be responsible for all QC test activities including but not limited to testing of Incoming materials, In Process Materials, Intermediate, API and Stability Sample, Method Transfer and Validation and Data Review.
The role will maintain the Quality System for QC; ensuring that Standard Operating and Analytical Procedures are in place, adhered to and that compliance with cGMP is maintained through ongoing training and process review.
This position is primarily an analytical laboratory function so will involve the majority of the time spent working in a laboratory.
- Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required.
- Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases through to commercial manufacturing.
- Preparation & review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP’s, calibration procedures, Analytical Test Records and miscellaneous protocols).
- Testing of Raw Material, Intermediates, API’s and materials associated with the reaction process and cleaning process in accordance with approved procedures including the stability testing program.
- Testing of Swab and Rinse samples and visual inspection of equipment after cleaning.
- Sampling and Testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring).
- Review and accuracy check of Analytical Data.
- Performing Own Training activities (reading acknowledgements, attendance at training events, online training completion).
- Active participation in laboratory Tier meetings.
- Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities.
- Participation in Instrumentation calibration & maintenance. Responsible for ensuring that laboratory equipment is maintained and functioning properly according to specifications.
- Laboratory system support (e.g. Maintain reference standards, retention samples, stability testing, vendor certification, Training system, HPLC & GC columns, Coordinate evacuations, shower checks, self-inspections, Quality and Safety inspections).
- Performing data trending.
- Record and update Laboratory metrics.
- Bachelor of Science in Chemistry with experience in a laboratory environment.
- Method Validation, HPLC and GC proficiency essential.
- Recognised LSS Qualification (Yellow Belt, Green Belt, Black Belt) desirable.
- This position will require fluent use of Laboratory Software tools e.g. Empower 3, Trackwise, SAP, Document Management, Learning Management.
- This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with Global QC Network and Quality Organization.
- Ability to develop and adhere to self-directed standard work.
- Demonstrated skills organizing and tracking data and documents.
- Proficient in English.
- Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives.
- Demonstrated written and oral communication skills, as well as experience with presenting to leadership teams.
- Must have strong technical/analytical skills and demonstrated commitment to delivering results.
- Due to a high volume of applications only those progressing to the next stage will be contacted.
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003