Overview
An amazing opportunity has arisen for an Associate Quality Specialist. The role supports day to day QA activities on site. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).
What You Will Do
* Participate as functional expert in the cross functional team that manages production right first time at site.
* Review and approve batch, cleaning and testing documentation.
* Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
* Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
* Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
* Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
* Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
* Ensure changes controls raised are documented, assessed and completed.
* Prepare Annual Process and System Reviews.
* Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
* Participate in the generation and communication of quality metrics.
* Creation, review and approval of quality procedures as required.
What Skills You Will Need
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
* Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
* Spray drying experience desirable.
* Knowledge and demonstrated expertise in Lean / Continuous Improvement.
* Experience and knowledge of GMP Requirements for Electronic /paper free operations.
* Experience in High potency manufacturing desirable.
* Communications Excellent written and oral communication skills. Organizes and delivers information appropriately.
* Team Work Interacts with people effectively. Able and willing to share and receive information.
* Decision Making Uses sound judgement to make good decisions based on information gathered and analysed.
* Adaptability Adapts to changing work environments, work priorities, organizational needs and diverse people.
* Work Standard Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
* Motivation Displays energy and enthusiasm. Maintains high level of productivity and self direction.
As a company, we are committed to ‘Inventing for Life’ in all that we do. 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.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, 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
Relocation
No relocation
VISA Sponsorship
No
Travel Requirements
10%
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
N/A
Required Skills
Adaptability, Adaptability, Analytical Problem Solving, Aseptic Manufacturing, Auditing, Continual Improvement Process, Corrective Action Management, Data Analysis, Decision Making, Dispensing Pharmacy, Environmental Monitoring, GMP Compliance, Laboratory Instrumentation, Laboratory Operations, Laboratory Testing, Oral Communications, Performance Monitoring, Pharmacy, Quality Assurance (QA), Quality Control Inspection, Quality Process Development, Raw Material Testing, Regulatory Compliance, Risk Assessments, Risk Control Assessment {+ 1 more}
Preferred Skills
Job Posting End Date
10/4/2025
Requisition ID
R367004
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