Job Description

Role

The Quality Control analyst reports to the QC Manager 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 Samples, Method Transfer and Validation and Data Review.

The role will maintain the Quality System for QC; ensuring that Standard Operating Procedures are in place and that compliance with cGMP is maintained through ongoing training and process review.

POSITION RESPONSIBILITIES

Key objectives of this position include:

1.Development, Validation and Transfer of Analytical Methods, including cleaning method validation and associated troubleshooting as required.

2.Analytical support to include monitoring of production and analytical results throughout the technology transfer and process validation phases.

3.Preparation & review of laboratory documentation (e.g. Method Transfer and Validation protocols and reports, SOP’s, calibration procedures, Analytical Test Records, and miscellaneous protocols).

4.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.

5.Testing of Swab and Rinse samples and visual inspection of equipment after cleaning

6.Sampling and testing of support utilities (Water, Nitrogen, Steam, Environmental Monitoring).

7.Review and accuracy check of Analytical Data

8.Performing Own Training activities (reading acknowledgments, attendance at training events, online training completion).

9.Active participation in laboratory Tier meetings.

10.Active participation in problem solving, troubleshooting, laboratory investigations, compliance related activities, audit observations, continuous improvement activities and Lean Six Sigma/Operational Excellence activities.

11.Participation in Instrumentation calibration & maintenance. Responsible to assure that laboratory equipment is maintained and functioning properly according to specifications.

12.Laboratory system support (e.g. Maintain reference standards, retention samples, vendor certification, Training system, HPLC & GC columns, Co-ordinate evacuations, shower checks, self-inspections, Quality and Safety inspections).

13.Ensuring that they perform their role to a high standard and deliver on objectives/duties assigned to them.

ORGANIZATIONAL RELATIONSHIPS

This position will need to achieve results through collaborating with colleagues (Site QC team) as well cross functionally to assure quality goals and objectives are met.

All colleagues must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.

All colleagues are expected to model inclusion behaviours.Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.

EDUCATION AND EXPERIENCE

•Bachelor of Science in Chemistry with a minimum of 2-3 years of quality control and analytical laboratory experience and proven experience in an analytical laboratory.

•HPLC experience essential and GC proficiency desirable.

•Recognised LSS Qualification (yellow belt, Green Belt, Black Belt) desirable

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

•Ability to develop and adhere to self-directed standard work.

•Demonstrated skills organizing and tracking data and documents.

•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.

•Drives for Superior Results and Passion to Win with demonstrated record in getting things done.

•Demonstrated ability to work with internal and external colleagues and ability to collaborate effectively with others.

•Flexible and adaptable to new and innovative ideas

•Proficient in English

PHYSICAL POSITION REQUIREMENTS.

•This is Rathdrum, Ireland Site based position.

•This position is primarily an analytical laboratory function so will involve majority of the time spent working on site in a laboratory.

•This position will require fluent use of Laboratory Software tools e.g. Empower 3, Trackwise, SAP, Document Management, Learning

•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

•The QC Analyst role must demonstrate flexibility in relation to types of work, shift patterns and locations of work at the Rathdrum site.

Full timeRegularColleague

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