Associate Specialist, Quality Assurance

Job DescriptionAssociate Specialist, Quality AssuranceLooking for a different challenge as a Associate Specialist, Quality Assurance whereby you can still utilise your skills?1 year Fixed Term Contract, Full-time position with competitive renumeration and benefitsHybrid, work from home and office environment, with a dedicated and welcoming teamUpskill and growth in an area you’re passionate about, whilst being fully supported and encouragedJoin a trusted Global Leading Pharmaceutical organisationWe are seeking a motivated and detail-oriented individual to join our team as a Quality Assurance Associate supporting Australia and New Zealand markets.This is an entry-level position that offers an excellent opportunity for professional growth in the field of commercial quality.What You Will DoResponsibilities include, however not limited to:Assist in the implementation and maintenance of Quality Assurance processes and procedures in accordance with regulatory requirements and company standards.Provide support to Australia and New Zealand Quality Responsible Person (QRP) Lead with any recall matters.Assist with the management for local vaccine release activities.Ensure periodic customer qualifications are performed in a timely manner.Support Australia and New Zealand Lead QRP with quality and compliance related activities at our company’s outsourced warehouses.Work closely with cross-functional teams to investigate and resolve quality issues, deviations, and non-conformances. Conduct root cause analysis and implement corrective and preventive actions.Support change control processes by assessing the impact of proposed changes on product quality and ensuring proper documentation and approval.Collaborate with internal teams to provide training and guidance on Quality Assurance processes, standards, and compliance requirements.Maintain accurate and up-to-date documentation related to Quality Assurance activities.What You Must haveBachelor's degree in a related field, such as Pharmacology, Science, Engineering, or a relevant discipline.Strong attention to detail and excellent organizational skills.Knowledge of Quality Assurance principles and processes, advantageous not essential.Familiarity with TGA and Medsafe regulatory requirements and industry standards, advantageous not essential.Good problem-solving and analytical skills, with the ability to conduct root cause analysis and implement corrective actions.Effective communication skills, both written and verbal.Ability to work well within a team and collaborate with cross-functional departments.Proficiency in using Microsoft Office applications and other relevant software systems.Prior experience or internships in a Quality Assurance, operation or regulatory role in pharmaceutical industry, advantageous not essential.What You Can ExpectWork autonomously whilst being supported, encouraged and being part of a trusted Global Leading Pharmaceutical organisationExposure to upskill and develop in your roleFlexibility and opening doors to other opportunities and skillsetsJoining a collaborative team of likeminded individualsWe 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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySecondary Language(s) Job Description:

• Assist in the implementation and maintenance of Quality Assurance processes and procedures in accordance with regulatory requirements and company standards.
• Provide support to Australia and New Zealand Quality Responsible Person (QRP) Lead with any recall matters.
• Assist with the management for local vaccine release activities.
• Ensure periodic customer qualifications are performed in a timely manner.
• Support Australia and New Zealand Lead QRP with quality and compliance related activities at MSD outsourced warehouses.
• Work closely with cross-functional teams to investigate and resolve quality issues, deviations, and non-conformances. Conduct root cause analysis and implement corrective and preventive actions.
• Support change control processes by assessing the impact of proposed changes on product quality and ensuring proper documentation and approval.
• Collaborate with internal teams to provide training and guidance on Quality Assurance processes, standards, and compliance requirements.
• Maintain accurate and up-to-date documentation related to Quality Assurance activities.
• Stay updated with relevant regulations, industry standards, and emerging trends in commercial Quality Assurance.
• Bachelor's degree in a related field, such as Pharmacology, Science, Engineering, or a relevant discipline.
• Strong attention to detail and excellent organizational skills.
• Knowledge of Quality Assurance principles and processes will be advantageous.
• Familiarity with TGA and Medsafe regulatory requirements and industry standards will be advantageous.
• Good problem-solving and analytical skills, with the ability to conduct root cause analysis and implement corrective actions.
• Effective communication skills, both written and verbal.
• Ability to work well within a team and collaborate with cross-functional departments.
• Proficiency in using Microsoft Office applications and other relevant software systems.
• Prior experience or internships in a Quality Assurance, operation or regulatory role in pharmaceutical industry will be advantageous.

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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: Temporary (Fixed Term)Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: Not ApplicableShift:Valid Driving License:Hazardous Material(s):