Quality Specialist 3 - Compliance and Audits

Merck Group • $70K — $106K *
Rockville, MD 20850In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a life science discipline.
  • 2+ years in internal/client audits or quality agreements in QA role.
  • 2+ years leading/reviewing root cause analysis (RCA) and CAPA for deviations in QA role.
  • Preferred experience in GxP CRO/CDMO/CTO environments.
  • Understanding of FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP, and ICH Q9/Q10.

Responsibilities

  • Lead/support client, internal, regulatory audits and inspections.
  • Manage audit preparation and track compliance initiatives.
  • Drive inspection readiness and track audit commitments including CAPAs.
  • Review and approve deviations, investigations, and change controls.
  • Serve as subject matter expert for root cause analysis and investigations.
  • Guide operational teams on regulatory compliance requirements.
  • Monitor quality metrics, identify issues, and lead improvement initiatives.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Additional perquisites.
Full Job Description
Your Role:

Quality Specialist 3 - GMP/GLP Compliance provides independent quality oversight within a GMP/GLP-regulated laboratory environment. This role ensures compliance with regulatory requirements, internal procedures, and client expectations through investigation management, risk-based decision making, audit support, inspection readiness, and continuous improvement. The position partners with operational, technical, and client stakeholders to maintain an effective and inspection-ready Quality Management System (QMS).
Key Responsibilities:
  • Lead or support client, internal, regulatory audits and inspections.
  • Lead audit preparation, audit response, and tracking of outstanding compliance initiatives.
  • Drive inspection readiness activities and track audit commitments, CAPAs, and compliance actions.
  • Review, approve, and/or lead deviations, investigations, CAPAs, effectiveness checks, change controls, and risk assessments.
  • Serve as a subject matter expert for root cause analysis (RCA) and quality investigations.
  • Interpret regulatory requirements and provide compliance guidance to operational teams.
  • Review and approve SOPs, GMP records, and other quality documentation.
  • Facilitate risk assessments using tools such as HACCP and FMEA.
  • Monitor quality metrics and trends, identify systemic issues, and lead continuous improvement initiatives.
  • Support client meetings, regulatory submissions, supplier qualification activities, and client quality agreements as needed.


Who You Are :

Minimum Qualifications:
  • Bachelor's degree in a life science discipline.
  • 2+ years' experience in conducting internal audits, client audits, or Client quality agreements in a Quality Assurance role.
  • 2+ years' experience in leading and/or reviewing root cause analysis and CAPA for deviations in a Quality Assurance role
Preferred Qualifications:
  • Experience in a GxP CRO/CDMO/CTO or multi-client environment.
  • Experience with inspection readiness programs and regulatory responses.
  • Experience analyzing compliance metrics and quality trends.
  • Working knowledge of FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP requirements, and ICH Q9/Q10.
  • Broad quality systems experience across multiple QA disciplines.
  • Experience in conducting supplier audits
  • Demonstrate proven track record of effective communication with internal stakeholders and external clients.
  • Strong analytical, communication, organizational, and problem-solving skills.
  • Demonstrated ability to work independently, influence stakeholders, and foster a culture of quality and compliance.


Pay Range for this position: $70,800-106,200 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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