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: 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.Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.Provides compliance contribution to project teams and leads small projects.May coach and guide colleagues within the site.Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.Ensure the highest Quality, Compliance and Safety standards.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:
Degree or 3?? level qualification (Science, Quality)1 - 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality functionDemonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e.
Quality, science etc.
)Operational experience of at least 4 QMSsQuality Assurance SME knowledge, from both operational and educational experience, is requiredKnowledge and experience in interpreting current regulatory requirements and providing independent support to the siteDemonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidanceDemonstrated ability to work and succeed within teams as well as leading small project teamsProven track record of providing independent Quality support to the site.
Advanced PC skills such as Excel, Word, PowerPointStakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levelsProven decision making capability with full accountability and responsibilityDemonstrated coaching skills and ability to solve problemsWe 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.
Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/19/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R343752
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