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Quality Specialist - External Manufacturing

Description

Want to drive specialist quality delivery? As Quality Specialist - External Manufacturing you’ll have the freedom raise standards within a specialist area for one of the world’s leading consumer goods businesses. 
 
Quality Specialist - External Manufacturing 
Parsippany, NJ 
Competitive Salary & excellent benefits package 

 
Ultimately responsible for in-country specialist commercial quality health support. You’ll ensure the quality management system exceeds global, local and industry standards. You’ll work with regulatory authorities to ensure compliance and best-practice. You’ll use data and reports to make informed decisions and focus on identifying areas for improvement. You’ll take the lead in process improvement. Above all, you’ll protect our reputation and guarantee our consumers continue to love our brands. 

 

You’ll succeed because… 
…you’re committed to raising standards. You’ve a background in quality and / or audit. You can influence others effectively. You know quality systems and tools. You’ve a broad knowledge of regulatory requirements within the healthcare or pharmaceutical sectors. You’re results-orientated, entrepreneurial and self-motivated. Above all, you can engage others and get them to share your mission to make lasting improvements. 

 

You’ll love it because… 
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day. 
 

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+ 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

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; 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. 


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

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