QC Analyst

Full Time
Rathdrum, County Wicklow
Posted
Job description

POSITION SUMMARY

The QC Analytical Chemist reports to the Rathdrum Site 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 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.

This position will execute restart activities to ensure that all new APIs manufactured at the site, API transfers and QC projects to support manufacturing are adequately supported through Analytical Department activities in line with Zoetis Policies and Global SOPs requirements.

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

POSITION RESPONSIBILITIES

Key objectives of this position include:

  • 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.
  • 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 acknowledgments, 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 to assure that laboratory equipment is maintained and functioning properly according to specifications
  • 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).
  • Performing data trending.
  • Record and update Laboratory metrics
  • Immediately notify any issues to the QC Head and support subsequent investigations
  • Responsible for ensuring that they understand and comply with all cGMP's associated with their job.
  • Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.
  • Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.
  • 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 as indirectly, as part of the site recommissioning core project team. The successful candidate will need to interact regularly with leadership at the site (Quality and site heads, site recommissioning project manager), GMT, regulatory affairs, to assure quality goals and objectives are met.

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

All employees 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 +10 years of quality control and analytical laboratory experience and proven experience in an analytical laboratory.
  • Method Validation, HPLC and GC proficiency essential
  • 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 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

About Zoetis

At Zoetis we are passionate about our customers and the animals in their care. We discover, develop and manufacture the world's most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry. We know our people drive our success. Our colleagues are proud of our company culture and the meaningful role we play in caring for animals. The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day. They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.

Diversity, Equity & Inclusion

Our Colleagues Make the Difference, and we know their differences make Zoetis stronger. We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day. Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry. Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives. In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality , a 100 Best Company for Working Mothers , a Top Company for Executive Women , among many others .

For animals. For health. For you.

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