Reckitt
R&D Associate
Reckitt, Salt Lake City, Utah, United States, 84193
We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.Research & DevelopmentIn R&D, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our R&D Academy, designed to develop our team and allow you to grow in our great organisation.About the roleKey responsibility: Ensure functionality, compliance, and support of R&D Quality Management System to a high standard, and QMS performance monitoring and continuous improvement.Ensure compliance of the R&D Quality Management System to internal and external GxP standards.Partner with R&D and other Cross-functional teams supporting the review and approval of QMS documentation including (non-inclusive): deviations, change controls, risk management, SOPs, batch manufacturing records (BMRs), sample release and others.Support the third-party vendor approval system collaboratively with Supply Quality and conduct audits both internally and supporting externally.Assist and support in the preparation and management of regulatory body and corporate inspections.
Scope - dimensions of role
The scope of the role will occasionally require guidance and demands great flexibility and appreciation of Quality Management System application in a Research and Development environment and new product launch activities on a global scale.Support creation of and deliver Quality specific training to the local R&D Teams.Support product launch activities whilst partnering cross functionally.Support the Internal and External Audits / schedule on an annual basis.Role is subject to changes in external standards and guidelines (regulatory body and corporate). This requires proactive coordination across all R&D categories and functions to ensure current regulatory expectations are being met.Role may require occasional travel to Reckitt Manufacturing and R&D sites and 3rd party vendors as part of R+D support, audit, and qualification activities.R&D may be subject to 2+ major inspections or audits per year from an external regulatory body in which the role will be required to support cross-functionally.
Your responsibilities*QMS: Ensure compliance R+D Quality Management System to current GxP standards and internal Reckitt requirements. Link with Global Quality Compliance and Supply Quality groups to maintain alignment and sharing of best practices to Global standards.
*R+D Development: Provides Quality input, reviews, approvals and support for R+D development projects on a tactical level enabling progress and improvements that realise product - may include: batch manufacturing records, Standard Operating Procedures, deviations, change controls, risk evaluation and management documents, validation documents and other quality related records as defined within the local QMS.
*Audit Program: Implement the annual internal and external audit schedule, conducts audits, provides suggestions for improvement and monitors completion of CAPA actions. Includes Supplier Management: Support 3rd party qualification program including the assessment, audit and approval of external GMP suppliers and service providers used during the development process. Participate in program with Supply Quality. Support maintenance of supplier list (ASL) for the facility locally and/or as part of a global system and ensures Technical Agreements are in place and are reviewed as per internal RECKITT requirements.
*Management Review: Support and participate in the R+D-VMS Quality Management Review. Includes KPIs: Responsible for the publishing of the defined Quality Management System monthly metrics (KPIs) locally and ensures metrics are communicated to the R+D Management Team. Monitors internal compliance trends (QMS trending) to identify areas of improvement and work with the R+D Team to drive key improvement initiatives that are identified through to completion.
*Product Release: Manage and perform quality release function for the R+D site supporting R+D Product Testing, Consumer, and Clinical Trials. Execute and maintain/improve quality release function supporting Consumer trials locally and as appropriate. Review systems in place locally are aligned with the Global R&D quality release systems.
*Document Management: Monitor metrics for DMS, review, improve and revise SOPs, Batch Manufacturing Records and validation documents. Review and approval of change control, deviations and out of specification/ out of trend (OOS/OOT) records.
*Training: Support creation, review and maintenance of R+D Training Program. Provides Training to Reckitt staff: including GMP and GCP Induction, assist in delivering Annual GMP Refresher training and other specific quality related training in-line with the standards defined in the QMS.
*Regulatory: Prepares for and takes an active part in supporting inspections by regulatory authorities and internal Reckitt audits. Monitors and supports completion of CAPA resulting from regulatory inspections. Proactively monitors and responds to changes in guidance and legislation issued by Regulatory Authorities.Key challanges
Proactive monitoring and timely implementation of changes and improvements to the local QMS.Maintaining a balanced compliance culture while supporting business deliverables. Partnering with the local R+D Teams where Quality is owned by all.Collaborate with R+D Category Teams on projects to ensure timelines are met in line with current regulatory and internal standards through on-time Quality deliverables.Ensures R+D QMS metrics are systematically published and improvement projects identified.Ability for unbiased and pragmatic evaluation and actioning of risk-based decisions and project risk mitigation activities is a significant challenge of the role.Execution and maintenance of "leading edge" quality management systems in-line with industry best practice. Maintaining awareness and knowledge of broad activities across R+D, Marketing and Supply, and integrating quality system needs as required for new product development and compliance.
The experience we're looking for
Degree or equivalent experience in a Science, Quality or Engineering disciplineLead Auditor training (i.e. IRCA qualified) - (preference)4+ years experience within a Healthcare, Dietary Supplement, or FMCG multidisciplinary environmentQuality Management System design, implementation and monitoring experience: To include experience with Quality System tools - such as QualityOne, Trackwise, MasterControl, Laboratory Information Management Systems (LabWare)Knowledge and awareness of general regulatory body requirements (FDA, ICH, EU, Etc.)Understanding R+D activities in product development and a basic understanding of the consumer product life cycle. Results oriented, entrepreneurial, and self-motivated, with strong planning and organisational capabilities, a bias for action, and the capability to define, evaluate and pragmatically action risksStrong analytical skills with the ability for critical thinking leading to development and execution of measurable implementation activities. Ability to transform critical thinking into concrete actions.Proficient IT skills: Microsoft Outlook, Word, Excel, and related office applications.
The skills for successR&D, Product Lifecycle Management, Commercial Awareness, Business Partnership, Collaboration, Partnership building, Collaborator, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability.What we offerWith inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.US salary rangesUSD$72,000.00- $108,000.00US pay transparencyThe base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law. In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year.Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, life and disability insurance; paid time off for vacation, sick, and Company recognized holidays; a 401(K) plan; generous paid parental leave; adoption and fertility support; tuition reimbursement; product discounts; and much more!If reasonable accommodation is needed to complete your application ,
please contact NAtalentacquisition@reckitt.com
.
Reckittis committed to the fullinclusion of all qualified individuals.EqualityWe recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our R&D Academy, designed to develop our team and allow you to grow in our great organisation.About the roleKey responsibility: Ensure functionality, compliance, and support of R&D Quality Management System to a high standard, and QMS performance monitoring and continuous improvement.Ensure compliance of the R&D Quality Management System to internal and external GxP standards.Partner with R&D and other Cross-functional teams supporting the review and approval of QMS documentation including (non-inclusive): deviations, change controls, risk management, SOPs, batch manufacturing records (BMRs), sample release and others.Support the third-party vendor approval system collaboratively with Supply Quality and conduct audits both internally and supporting externally.Assist and support in the preparation and management of regulatory body and corporate inspections.
Scope - dimensions of role
The scope of the role will occasionally require guidance and demands great flexibility and appreciation of Quality Management System application in a Research and Development environment and new product launch activities on a global scale.Support creation of and deliver Quality specific training to the local R&D Teams.Support product launch activities whilst partnering cross functionally.Support the Internal and External Audits / schedule on an annual basis.Role is subject to changes in external standards and guidelines (regulatory body and corporate). This requires proactive coordination across all R&D categories and functions to ensure current regulatory expectations are being met.Role may require occasional travel to Reckitt Manufacturing and R&D sites and 3rd party vendors as part of R+D support, audit, and qualification activities.R&D may be subject to 2+ major inspections or audits per year from an external regulatory body in which the role will be required to support cross-functionally.
Your responsibilities*QMS: Ensure compliance R+D Quality Management System to current GxP standards and internal Reckitt requirements. Link with Global Quality Compliance and Supply Quality groups to maintain alignment and sharing of best practices to Global standards.
*R+D Development: Provides Quality input, reviews, approvals and support for R+D development projects on a tactical level enabling progress and improvements that realise product - may include: batch manufacturing records, Standard Operating Procedures, deviations, change controls, risk evaluation and management documents, validation documents and other quality related records as defined within the local QMS.
*Audit Program: Implement the annual internal and external audit schedule, conducts audits, provides suggestions for improvement and monitors completion of CAPA actions. Includes Supplier Management: Support 3rd party qualification program including the assessment, audit and approval of external GMP suppliers and service providers used during the development process. Participate in program with Supply Quality. Support maintenance of supplier list (ASL) for the facility locally and/or as part of a global system and ensures Technical Agreements are in place and are reviewed as per internal RECKITT requirements.
*Management Review: Support and participate in the R+D-VMS Quality Management Review. Includes KPIs: Responsible for the publishing of the defined Quality Management System monthly metrics (KPIs) locally and ensures metrics are communicated to the R+D Management Team. Monitors internal compliance trends (QMS trending) to identify areas of improvement and work with the R+D Team to drive key improvement initiatives that are identified through to completion.
*Product Release: Manage and perform quality release function for the R+D site supporting R+D Product Testing, Consumer, and Clinical Trials. Execute and maintain/improve quality release function supporting Consumer trials locally and as appropriate. Review systems in place locally are aligned with the Global R&D quality release systems.
*Document Management: Monitor metrics for DMS, review, improve and revise SOPs, Batch Manufacturing Records and validation documents. Review and approval of change control, deviations and out of specification/ out of trend (OOS/OOT) records.
*Training: Support creation, review and maintenance of R+D Training Program. Provides Training to Reckitt staff: including GMP and GCP Induction, assist in delivering Annual GMP Refresher training and other specific quality related training in-line with the standards defined in the QMS.
*Regulatory: Prepares for and takes an active part in supporting inspections by regulatory authorities and internal Reckitt audits. Monitors and supports completion of CAPA resulting from regulatory inspections. Proactively monitors and responds to changes in guidance and legislation issued by Regulatory Authorities.Key challanges
Proactive monitoring and timely implementation of changes and improvements to the local QMS.Maintaining a balanced compliance culture while supporting business deliverables. Partnering with the local R+D Teams where Quality is owned by all.Collaborate with R+D Category Teams on projects to ensure timelines are met in line with current regulatory and internal standards through on-time Quality deliverables.Ensures R+D QMS metrics are systematically published and improvement projects identified.Ability for unbiased and pragmatic evaluation and actioning of risk-based decisions and project risk mitigation activities is a significant challenge of the role.Execution and maintenance of "leading edge" quality management systems in-line with industry best practice. Maintaining awareness and knowledge of broad activities across R+D, Marketing and Supply, and integrating quality system needs as required for new product development and compliance.
The experience we're looking for
Degree or equivalent experience in a Science, Quality or Engineering disciplineLead Auditor training (i.e. IRCA qualified) - (preference)4+ years experience within a Healthcare, Dietary Supplement, or FMCG multidisciplinary environmentQuality Management System design, implementation and monitoring experience: To include experience with Quality System tools - such as QualityOne, Trackwise, MasterControl, Laboratory Information Management Systems (LabWare)Knowledge and awareness of general regulatory body requirements (FDA, ICH, EU, Etc.)Understanding R+D activities in product development and a basic understanding of the consumer product life cycle. Results oriented, entrepreneurial, and self-motivated, with strong planning and organisational capabilities, a bias for action, and the capability to define, evaluate and pragmatically action risksStrong analytical skills with the ability for critical thinking leading to development and execution of measurable implementation activities. Ability to transform critical thinking into concrete actions.Proficient IT skills: Microsoft Outlook, Word, Excel, and related office applications.
The skills for successR&D, Product Lifecycle Management, Commercial Awareness, Business Partnership, Collaboration, Partnership building, Collaborator, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability.What we offerWith inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.US salary rangesUSD$72,000.00- $108,000.00US pay transparencyThe base salary range for this role will vary based on experience in job and industry, training and education, skills relevant to the position, and other factors permitted by law. In addition to the base salary, the position is eligible for an annual discretionary bonus, which is subject to change each year.Reckitt offers eligible employees competitive benefits including medical, prescription, dental, vision, life and disability insurance; paid time off for vacation, sick, and Company recognized holidays; a 401(K) plan; generous paid parental leave; adoption and fertility support; tuition reimbursement; product discounts; and much more!If reasonable accommodation is needed to complete your application ,
please contact NAtalentacquisition@reckitt.com
.
Reckittis committed to the fullinclusion of all qualified individuals.EqualityWe recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.