Quality Operations Specialist/Lead - Molecular Cell Biology

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

 

Job Description

Quality Validation Specialist 

Department: Molecular Cell Biologist, Dungarvan

Reports to: Team Leader / Snr. Manager

 

Reports to:  MCB Senior Manager

Job Summary

The purpose of this job is to support management of the implementation and development of the Quality aspects of the Molecular Cell Biology Department and any support departments as required.  The Quality Operations Specialist must ensure appropriate systems and controls are implemented to facilitate both customer and quality requirements. The Molecular Cell Biology team must be led, motivated and developed in the area of quality so that they are able to react effectively to the changing business needs while maintaining quality compliance.

Job Responsibilities

 

  • To effectively manage and report all Quality Metrics within the Molecular Cell Biology team including Exceptions, CAPA’s, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance  with company metrics
  • Completion of Molecular Cell Biology approval of Quality documentation e.g. Exceptions, CAPA’s, SOP’s, Quality and technical agreements.
  • Lead cross functional risk assessment as required within the team
  • Assist in problem solving within the department. Lead where possible cross functional risk assessment within the team.
  • To ensure processes and systems are in place to ensure that Quality/ CAPA related project work is completed as required and associated customer reports are available in a timely manner.
  • To provide continuous feedback to all members of the team on all items in relation to customer or Quality requirements/changes.
  • Responsibility for managing the completion of compendia updates assessments for the department.
  • Responsible for supporting department leadership in ensuring the quality of the day to day work emanating from their laboratory and for problem solving any quality issue with other team members of the organisation.
  • To handle assigned customer related query and lead the investigation of any complaint, liaising with their team to problem solve these queries if needed.
  • To support internal and External/regulatory audits for area of responsibility, including audit preparation, queries during the audit and follow up of actions to closure. Finalising CAPA’s and associated deadlines.
  • To represent Molecular Cell Biology in the Change control Review board and equipment meetings as required. Assign and track actions within the team as appropriate.
  • To approve and keep updated laboratory SOPs in their area of work.
  • To identify any opportunities for improvement of quality and customer service and support the team to implement continuous improvement initiatives/projects.
  • To establish and manage key metrics in the areas of quality, customer satisfaction/delivery. Ensuring specific targets are set, met and any trends noticed are addressed. 
  • To ensure the quality of the day-to-day work of the team continues to meets company standards and for problem solving any quality issues with other members of the organisation.
  • To ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.
  • To communicate regularly with their team and all other ancillary groups to ensure information is transferred effectively throughout the organisation. Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas of Quality.
  • Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
  • Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
  • To continually liaise with management, customers and other members of the organisation on any relevant problem areas or enhancements to the business.
  • To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.

 

Qualifications

A degree in Molecular Cell Biology

A working knowledge of QMS

Additional Information

Additional Company Benefits

Additional holiday leave

Birthday day

Attendance award

Paid Maternity Leave

Marriage leave

Free Tea & Coffee

Training and Development

Study support

Free parking

Income protection

Death in service

Sports & Social Club

Corporate Social responsibility day

Salary and bonus reviewed annually

Paid Sick leave

Finder’s Fee

Recognition program

Health insurance (Dependent on length of service/role)

Contributory pension (Dependent on length of service/role)

 

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