Associate Specialist, Quality Assurance

Job Description >

An amazing opportunity has arisen for a Part Time Associate Quality Specialist. This is an 8 hour per week position.

What You Will Do

• Right-First-Time Performance Participate as a functional quality expert in the cross-functional team that manages site production Right-First-Time (RFT) performance.
• Deviation & OOS Oversight Provide support to deviation investigations and Laboratory Out of Specification (OOS) / Out of Trend (OOT) investigations. Perform technical trending on deviations to identify improvement initiatives.
• Root Cause & CAPA Apply detailed knowledge of quality systems to ensure that robust root cause analysis is performed and effective Corrective and Preventive Actions (CAPA) are completed.
• Analytical & Microbiology QA Support Provide QA compliance support for site chemistry and microbiology laboratories. Review and approve analytical/microbiological method validation, verification, and transfer protocols and reports (e.g., HPLC, bioburden, endotoxin testing) in line with regulatory guidelines.
• Material Expiry Evaluation Evaluate raw material, intermediate, and API stability data to technically support and justify shelf-life/expiry extensions and retest date evaluations.
• Annual Reviews Prepare Annual Process, System, and Product Reviews.
• Quality & Change Agreements Coordinate and maintain the site's Quality Agreements (QAs) and Change Agreements (CAs) registers, authoring or revising active agreements as required.
• Internal Audit Programme Active participation in the site internal audit programme, including scheduled GMP audits and routine internal walkdowns, to drive site compliance and inspection readiness.
• Quality Metrics Contribute to the generation, analysis, and communication of site quality metrics for site Quality Councils and leadership.
• Documentation & Governance Create, review, and approve standard quality procedures as required.
• Continuous Improvement Provide feedback on recurring issues to ensure continuous improvement of site systems and processes.

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, Document Management Systems).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.
• 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, organisational 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.

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,

Required Skills

Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, Audit Processes, CAPA Management, cGMP Compliance, Complaint Management, Compliance Activities, Corrective Action Management, Decision Making, Deviation Management, Document Management, Evaluate Information, Good Manufacturing Practices (GMP), Information Assurance Management, Productivity Management, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Metrics, Quality Standards, Quality Support, Root Cause Analysis (RCA) + 7 more

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

Flexible Work Arrangements

Hybrid

Requisition ID

R416501