Quality Control Validation Scientist

Merck Group$64K — $107K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemistry, Biochemistry, Biology, or a related life science discipline.
  • 5+ years of GMP experience in the pharmaceutical, biopharmaceutical, or chemical industry.
  • 2+ years of experience validating analytical and cleaning methods preferred.
  • Experience with analytical methods for bio-organics, proteins, or bio-conjugates using various techniques like UV, HPLC, GC, and wet chemistry.
  • Strong technical writing and root cause analysis skills.

Responsibilities

  • Perform analytical method and cleaning validations for commercial product release.
  • Write method-specific protocols, standard operating procedures (SOPs), and final reports for validations.
  • Execute and review laboratory testing per Good Documentation Practices (GDP) and validation protocols.
  • Lead troubleshooting and process improvement initiatives to enhance lab performance.
  • Draft and review analytical methods and operational protocols for non-validated methods.
  • Conduct technical reviews of assays and GMP documentation while maintaining laboratory safety standards.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO).
  • Retirement contributions.
  • Eligibility for sales or performance-based bonuses.
Full Job Description
Your Role

The Quality Control Validation Scientist is a critical role within the QC department, responsible for executing analytical method validations to support the testing of raw materials, intermediates, stability samples, and finished goods. Operating strictly in accordance with ICH and cGMP guidelines, this position ensures all testing processes meet the highest regulatory standards for product quality and compliance.

  • Perform analytical method and cleaning validations to support the release of commercial products, preferably with prior pharmaceutical industry experience
  • Write method-specific protocols, standard operating procedures (SOPs), and comprehensive final reports for assigned validation projects
  • Execute and review laboratory testing in strict accordance with Good Documentation Practices (GDP) and specific validation protocols
  • Lead technical troubleshooting and process improvement initiatives to optimize laboratory performance, managing project milestones for internal and external stakeholders to ensure on-time, high-quality deliverables
  • Draft and review analytical methods, equipment procedures, and operational protocols for non-validated methods as assigned
  • Perform technical reviews of assays and other GMP documentation while actively working in accordance with current cGMPs and championing proper laboratory safety and housekeeping practices


Who You Are

Minimum Qualifications:

  • Bachelor's degree in Chemistry, Biochemistry, Biology, or other life science discipline
  • 5+ years of GMP experience in the pharmaceutical, biopharmaceutical or chemical industry


Preferred Qualifications:

  • 2+ years of experience validating analytical methods and cleaning methods
  • Experience performing, reviewing, and troubleshooting analytical methods for bio-organics, proteins, or bio-conjugate products, using techniques such as UV, HPLC, GC, iCE, CGE, and wet chemistry
  • Strong background in technical writing, root cause analysis, and scientific reasoning
  • Proven ability to communicate effectively within cross-functional teams and collaborate directly with external customers


Pay Range for this position: $64,900 - 107,900 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.

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.
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