Quality Assurance (QA) Associate/Specialist
ReckittAbout the role
We are Reckitt
Home 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 & Development
In 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.
Position summary
The incumbent supports the organization in the development, improvement and implementation of the organization’s Quality System under the direction of Quality Management, with a key focus on the maintenance and further development of the Reckitt QMS Document Control and Training programs. This position is responsible for ensuring that the Business Unit maintains compliance with applicable FDA cGMP regulations; especially regarding the compliance of the Document Control and Training programs that deploy these documents to our employees. This employee must be able to self-manage and work effectively with internal parties as well as Reckitt partners and external Reckitt employees (non-US) with very little direct oversight. Employees in this job will be required to develop and support the Reckitt deployment of Veeva QualityOne as our new QMS system, transferring existing SOPs to the new system as well as developing new Training deployment curriculums/matrices to ensure the right training is reaching the right resources.
Duties & Responsibilities
Short Term Duties and Responsibilities related to Veeva QualityOne Deployment:
- Must work to organize and prepare the current QMS Document Control (approx. 200 Approved/Effective SOPs/Documents) and Training systems (approx. 600 Employees) for deployment to QualityOne.
- Must familiarize and align with the QualityOne global deployment team acting as a lead for the US to coordinate and plan activities necessary for deployment to QualityOne system.
- Must complete training and familiarize with the QualityOne system- working with Global Teams to gather information and resources to build Subject Matter Expert Knowledge.
- Some travel to support this deployment may be required, but is not typical for the role ongoing.
Long Term Duties:
- Ability to write and review SOPs content for compliance, formatting, and effective Document Control schemes, implementing best practices for SOP writing as well as Document Control for the continued updates of SOPs over time.
- Work with other Employees and Departments, potentially externally, acting as a project manager in situations which you are not the Subject Matter Expert to guide the SOP Writing process and ensuring that SOPs are written where needed, approved and made effective.
- Maintain the accuracy of the Document Control system by implementing new procedures into the QMS an Maintaining all aspects of a functioning QMS System including archival, periodic review and obsoletion where needed.
- Creation and maintenance of Training Curriculum/Matrices for deployment of SOPs to the correct employees for training and use.
- Creation of Quizzes and Tests associated with Critical Documents and deployment through QMS Software.
- Working with Human Resources to identify new employees and assign them to the correct training curriculums/matrices within the new hire timeframe to ensure new employees will start with SOP assignments ready for them.
- Performs new hire orientations with new employees to welcome them to Reckitt as well as welcome them and familiarize them with our QMS systems.
- Work to achieve and maintain KPI Targets for Document Control and Training as deployed by QA Management.
- Hold/hosts/coordinates live training sessions for critical SOP updates and deployments.
- Act as a Subject Matter Expert for other
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