An amazing opportunity has arisen for a Quality Assurance Specialist as a core member of the Process IPT (Integrated Process Team). At our site we bring new products to the market with a variety of technologies, experience in Active Pharmaceutical Ingredients, Spray Dried Intermediate, Oral Solid Dose and or High Potency products would be preferred for the ideal candidate.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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, investigated 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 and improve efficiencies where opportunities are identified.
• 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:

In order to excel in this role, you will more than likely have:

• Degree or post-graduate qualification in Chemistry, Science, Pharmacy with 5 years working in a QA role or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, QSAT).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.
• Experience in High potency/ Spray drying/API/OSD/Laboratory/Project Management desirable. Communication skills: Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately.
• Team Work skills: Interacts with people effectively. Able and willing to share and receive information.
• Decision Making skills: 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R214214