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Quality Specialist (Associate level), External Manufacturing Operations (EMO)

About the role

 

This Quality Specialist will be responsible for ensuring that NA Hygiene products manufactured at third party contract sites comply with all the applicable regulations as well as with our corporate quality standards during their whole life cycle.

 

This professional will interface with several areas and will work closely with the Supply teams providing guidance on the Quality requirements for the qualification and maintenance of new suppliers, processes, and products.  The role would also support continuous improvement efforts at existing manufacturing sites. 

Key Responsibilities

 

•    Provide Quality support for all external manufacturing related activities such as new projects, the resolution of questions or complaints, and ensuring end-to-end success of projects.

 

•    Partner with the Supply teams in assuring that the stages of the development process comply with all our Quality corporate requirements.

 

•    Analyze and prepare Quality documentation for the launch of new products and for the change of the existing ones, such as technical manuals, technical agreements and good for sale certificates.

 

•    Perform Quality risk assessments for new and existing external manufacturing operations.

 

•    Act as Quality representative during trials and validation activities at external manufacturers.

 

•    Lead the scheduling, execution, reporting and tracking of onsite audits of external manufacturers to confirm that these operations are performed in compliance with Reckitt’s Global QMS and meet all relevant regulatory requirements.

 

•    Maintain quality system processes, such as Change Control, Supplier Management, Deviations and Investigations, CAPA, and others as needed.

 

•    Track audit findings for suppliers to completion and ensure timely closure of audit reports and ensure adequate CAPAs are developed by suppliers and monitor their closures.

 

•    Analyze errors and deviation from process and procedures, hold key stakeholders accountable, and provide guidance on key actions and steps required to correct deviations.

Qualifications

 

•    Minimum of a BA or BS degree, preferably in engineering, life, or natural sciences.
•    4+ (- 9) years’ experience in Quality Assurance / Quality Control Systems in a regulated environment.
•    Must be quality-focused and detail-oriented.
•    Must possess the competence to perform tasks requiring analytical and problem-solving skills.
•    Must demonstrate outstanding teamwork in interacting with other team members.
•    Excellent written and verbal communication skills, problem-solving, decision-making skills, and computer proficiency.
•    Experienced in Good Manufacturing Practices.
•    Experienced in quality systems, such as ISO 9000, GMP, HACCP, and Auditing.
•    Experience conducting audits including planning and follow-up on CAPAs resulting from the findings.
•    Travel required (approx. 25- 50%).

Equality

In Return Reckitt offers very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
Reckitt is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Nearest Major Market: New York City
Nearest Secondary Market: Newark

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