Job Description
A fantastic opportunity has arisen for a Quality Associate Specialist/ Specialist.
The Quality Associate Specialist/ Specialist will provide Quality oversight, support and knowledge to activities relating to all Operations and Quality Systems across the site. The expectation is that the colleague will be required to work on a shift basis to support ongoing Manufacturing Operations during weekdays and at weekends. This will be a 2 cycle shift pattern.
Bring Energy, Knowledge, Innovation To Carry Out The Following
1. Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/Investigations/; Change Management, environmental monitoring program, sterility assurance/ low bio-burden manufacturing, customer complaint investigations etc.
2. Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
3. Provides compliance contribution to project teams and leads small projects.
4. May coach and guide colleagues within the site.
5. Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
6. Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
7. Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
8. Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
9. Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
10. Ensure the highest Quality, Compliance and Safety standards.
11. The Associate Specialist/ Specialist will participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership.
What Skills You Will Need
In order to excel in this role, you will more than likely have:
1. Degree or 3ʳᵈ level qualification (Science, Quality)
2. 1 - 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
3. Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.)
4. Operational experience of at least 4 QMSs
5. Quality Assurance SME knowledge, from both operational and educational experience, is required
6. Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
7. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
8. Demonstrated ability to work and succeed within teams as well as leading small project teams
9. Proven track record of providing independent Quality support to the site. Advanced PC skills such as Excel, Word, PowerPoint
10. Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
11. Proven decision making capability with full accountability and responsibility
12. Demonstrated coaching skills and ability to solve problems.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application.
So, If You Are Ready To
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Requisition ID: R343752
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