Quality Assurance Specialist 3

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

Qualifications

  • Bachelor's Degree in Biology, Chemistry, Engineering, or related field with 4+ years in Quality Assurance within a GxP setting.
  • At least 1 year of experience in root cause analysis and CAPA review.
  • Proficient knowledge of FDA and EU regulations regarding cGMP, GLP, and Data Integrity.
  • Strong communication and interpersonal skills.
  • Demonstrated ethical work quality and flexibility.

Responsibilities

  • Conduct audits and approve regulated documentation including RCA analyses and CAPA records.
  • Train and mentor peers on root cause investigative techniques.
  • Analyze investigation information and communicate findings and recommendations.
  • Review and approve change control records and conduct effectiveness checks on CAPA actions.
  • Support regulatory inspections by acting as a Quality subject matter expert during audits.
  • Author and review Standard Operating Procedures (SOPs) and quality policy documents.
  • Participate in projects as a quality subject matter expert, fostering collaboration across departments.

Benefits

  • Health insurance offering comprehensive coverage.
  • Paid time off (PTO) to support work-life balance.
  • Retirement contributions for future financial security.
  • Potential eligibility for performance-based bonuses.
Full Job Description
Your Role:

At MilliporeSigma, as a Quality Assurance Specialist 3, your tasks will include conducting audits and review/approval of various types of regulated documentation.
  • Review and approve RCA analysis for robustness and accuracy and/or perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA.
  • Train and/or provide peer mentorship in the root cause Investigative Process and techniques.
  • Analyze and evaluate information captured through investigations, communicate findings and recommendations Review and approve OOS, trend, critical-impact deviations and lower impact deviations and conduct trend analysis for deviations.
  • Review / approve applicable CAPA records and conduct Effectiveness checks.
  • Review and approve change control (GCC) records.
  • Train Quality Specialists and/or Operations teams on quality topics.
  • Provide support for regulatory inspections and for client regulatory submissions.
  • Act as Quality SME during regulatory inspections and customer audits for areas of expertise.
  • Conduct laboratory inspections to include internal audits and assay methods.
  • Author, review and approve standard operating procedures (SOPs), quality policy documents.
  • May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
  • May review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
  • May review and approve validation files for systems and assays.
  • Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
  • May perform risk assessment using various methodologies.


Who You Are

Minimum Qualifications:
  • Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.
  • 1+ years' experience in conducting and/or reviewing root cause analysis and CAPA for deviations and out-of-specification (OOS) results in a Quality Assurance role


Preferred Qualifications:
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
  • Excellent communication and interpersonal skills.
  • Ensures quality of own work in an ethical manner.
  • Open-minded, flexible and works with agility.
  • Meets assigned deadlines.
  • 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

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.

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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