Quality Assurance Specialist

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Specialist (P2) is responsible for supporting Quality Systems processes related to Health Authority reporting, product complaint intake and assessment, adverse event management, and complaint sample coordination. This role ensures compliance with global regulatory requirements, internal quality standards, and company procedures for the timely evaluation, documentation, investigation, and reporting of product quality complaints and adverse events.

The successful candidate will serve as a key liaison between Quality Assurance, Pharmacovigilance, Manufacturing, Regulatory Affairs, and external stakeholders to ensure accurate complaint processing, effective sample management, and regulatory reporting activities.

In addition, responsible for carrying out divisional requirements as necessary. Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance.

• →Author Adverse Event Quality Investigation Reports
• →Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples.
• →Maintain complaint sample inventory and chain-of-custody records.
• →Work with laboratories and investigation teams to ensure complaint samples are tested within established timelines.
• →Ensure complaint samples are handled and retained according to GMP and company requirements.
• →Support sample reconciliation activities and maintain accurate documentation.
• →Author Health Authority responses and notifications

• →Review and update procedures, work instructions, and training materials related to complaint handling and reporting processes.
• →Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information
• →Participates on teams supporting internal functions and/or evaluating site processes for improvement opportunities
• →Provides information for regulatory inspections as requested
• →Completes special projects or assignments as directed by management including conducting education and training on GMP requirements
• →Individual may have the opportunity to support other areas within the West Point Quality Assurance organization, including:
  • →SOP and Batch Record Management
  • →Audits and Inspections
  • →Deviation Management
  • →Annual Product Reviews, Vendor Management
  • →Inspection Management, QMS/Quality Council Management
  • →Risk Management

• →Interprets customer needs, assesses requirements and identifies solutions to non-standard requests
• →Explains difficult issues and works to build alignment around a complex situation
• →Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities

• Bachelor’s degree*. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
• * In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.
  

• Minimum three (3) years in Pharmaceutical Quality, Quality Assurance, Quality Systems, Product Complaints, Pharmacovigilance, or related experience with progressive and demonstrated Quality decision-making responsibility
• Experience working in a regulated GMP environment required.
• Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
• Demonstrated self-starter with capability to develop innovative solutions to challenges
• Deliver results across multiple functional areas at the site.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
• Speaks with courage and candor
• Effective and positive written and verbal communication skills
• In-depth working knowledge and application of GMPs

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Current Employees apply HERE

Current Contingent Workers apply HERE

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.