Specialist, Quality Assurance

Merck Group • $69K — $110K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • High School Diploma or GED required
  • 2+ years of quality assurance experience in GMP regulated environments
  • Bachelor's Degree preferred
  • Knowledge of manufacturing processes and controls for commercial/clinical products is a plus
  • Strong communication skills for internal and external interactions
  • Capacity to train others in pharmaceutical manufacturing quality activities
  • Ability to work independently and in a team-focused environment

Responsibilities

  • Conduct detailed review of Batch Manufacturing Records and cGMP documents for compliance
  • Assess batch records for accuracy and adherence to proper documentation practices
  • Identify and report discrepancies, coordinating corrections with Manufacturing teams
  • Initiate deviations and investigations for batch record issues that require formal escalation
  • Work with teams to enhance documentation quality through feedback and trend analysis
  • Monitor and report review cycle times to ensure timely product release
  • Maintain in-depth knowledge of manufacturing processes and controls for effective review

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Additional prerequisites as per company policy
Full Job Description
Your Role:

In this role you will perform Quality Document Control and Product Release activities within a complex parenteral manufacturing facility, including Batch Record Review and Product Release, Batch Record Issuance, Document Control/Archival, and related investigations/CAPAs and Training. The position collaborates with other QA personnel, Quality Control, Operations, Clients, and Suppliers to establish and maintain requirements for product release and document management. Responsible for ensuring that all products manufactured and/or supported meet established specifications and regulatory requirements.

Responsibilities include but are not limited to:
  • Perform thorough, quality review of completed Batch Manufacturing Records (MPCRs) and associated executed cGMP documents for commercial drug product lots in accordance with site SOPs and applicable regulatory requirements.
  • Evaluate completed batch records for accuracy, completeness, legibility, proper documentation practices (GDP), and compliance with approved manufacturing instructions, in-process specifications, and acceptance criteria.
  • Identify, document, and communicate errors, omissions, and discrepancies found during batch record review, working directly with Manufacturing personnel and frontline supervisors to initiate timely and appropriate corrections in compliance with GDP requirements.
  • Initiate or support the initiation of deviations and investigations in the eQMS for batch record discrepancies that cannot be corrected via standard GDP correction practices, ensuring proper escalation and documentation.
  • Collaborate with the Batch Record Review team and Manufacturing to drive continuous improvement in documentation quality, reducing recurring errors through targeted feedback, trend analysis, and retraining recommendations.
  • Track and report batch record review cycle times to support on-time lot disposition and maintain alignment with established release timelines.
  • Maintain working knowledge of the product-specific manufacturing processes, equipment, and in-process controls associated with all commercial products manufactured at the site to support effective and knowledgeable batch record review.


Who You Are:

Minimum Qualifications:
  • High School Diploma or GED.
  • 2+ years of quality assurance experience within GMP regulated environment.


Preferred Qualifications:
  • Bachelor's Degree.
  • Knowledge of product-specific manufacturing processes, equipment, and in-process controls associated with commercial/clinical products manufactured to support effective and knowledgeable batch record review preferred
  • Ability to operate with a high level of autonomy and collaborate effectively with others.
  • Essential knowledge of cGMPs.
  • Strong oral and written communication skills, including internal and external interface.
  • Ability to train and qualify others in pharmaceutical manufacturing quality activities.
  • Strategic perspective with self-motivation, resilience, team orientation, and results-driven approach.


Pay Range for this position: $69,200 - $110,900 / year

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 prerequisites. 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

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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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