Quality Specialist 3 - Quality Systems

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 relevant field
  • 4+ years of Quality Assurance experience in a GxP environment
  • Practical knowledge of regulatory standards such as 21 CFR 11, EU GMP, and ISO 9001
  • Excellent written and verbal communication skills
  • Ability to work effectively in cross-functional teams

Responsibilities

  • Authorize, review, and approve quality documents
  • Lead investigations of deviations and complaints
  • Conduct root cause analysis using established methodologies
  • Review and approve CAPAs and analyze trends for effectiveness
  • Facilitate change control committee meetings
  • Provide training on quality management system records
  • Host and support internal and supplier audits

Benefits

  • Health insurance coverage
  • Paid time off (PTO)
  • Retirement contributions
  • Performance-based bonuses
  • Development opportunities in quality systems and regulatory compliance
Full Job Description
Your Role:

The Quality Specialist 3 supports our Contract Testing Services by ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements. This role independently performs routine to moderately complex quality tasks. Responsible for executing quality systems activities, including document review, investigations, and audit support. Works collaboratively with various teams including QA and Operations to support compliance and maintain quality standards while developing proficiency in quality systems and regulatory requirements.

  • Author, review and/or approve controlled quality documents, including SOPs, laboratory and batch records, and other quality records.
  • Review and approve events/deviations, out-of-specification investigations, complaints, and other investigations of varying impact and criticality.
  • Lead root cause analysis via use of approved tools (e.g., Fishbone, GEMBA).
  • Own and/or review and approve CAPAs and conduct trend analysis to facilitate verification of CAPA effectiveness.
  • Support customer discussions related to investigations and CAPAs.
  • Host change control committee meetings, review and approve change controls.
  • Assist with developing training material and provide training for review and approval of QMS records and other controlled quality documents.
  • Review study-related documents (e.g., protocols, technical specifications, data, certificates of analysis).
  • Host customer, internal and/or supplier audits in accordance with applicable cGMP/GLP requirements.
  • Review and approve audit responses and applicable follow-up actions/CAPAs.
  • Support regulatory inspections and maintain awareness of inspection readiness requirements.
  • Support continuous improvement initiatives to enhance quality and compliance.
  • Support maintenance of SOPs and adherence to global regulatory (e.g., FDA, EMA) and internal requirements.
  • Ensure accuracy, completeness, and compliance of documentation.
  • Audit and inspection readiness


Who You Are

Minimum Qualifications:

  • Bachelor's Degree
  • 4+ years' experience in Quality Assurance within a GxP environment.


Preferred Qualifications:

  • Practical knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines.
  • Excellent communication and interpersonal skills.
  • Ensures quality of own work in an ethical manner.
  • Open-minded, flexible and works with agility.
  • Works with cross-functional teams and builds networks within QA and Operations departments.
  • Collaborates with various teams to identify and implement improvements.
  • Willing to embrace and implement change on a global scale.


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.

RSREMD

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.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

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READ CAREERS BLOG

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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