Merck & Co, Inc

Senior Specialist, Quality Assurance (Hybrid)

Merck & Co, Inc • $106K — $167K *
Rahway, NJ 07065Hybrid
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5+ years of relevant experience in the Pharmaceutical or Biotechnology sector with a Bachelor's degree; 3+ years with an advanced degree.
  • Experience in Biologics Quality and Manufacturing, including pilot and commercial scale operations;
  • In-depth understanding of Current Good Manufacturing Practices (cGMP);
  • Experience interpreting health authority regulations in a research & development context;
  • Strong project management skills to handle multiple priorities and timelines;
  • Excellent communication skills for collaboration and conflict resolution.

Responsibilities

  • Provide Quality oversight for manufacturing and testing operations with a focus on documentation reviews.
  • Identify compliance risks and escalate issues to ensure quality in the biologics clinical space.
  • Collaborate cross-functionally to support the compliant execution of GMP activities.
  • Implement a quality-by-design approach through effective use of quality systems and documentation controls.
  • Cultivate partnerships with stakeholders, assisting with quality events and decision-making processes.
  • Promote a culture of compliance and continuous improvement through training and quality monitoring.
  • Ensure departmental procedures adhere to current regulations and manage SOP reviews.
  • Act as Quality representative on project teams, establishing quality standards and oversight.

Benefits

  • Hybrid work arrangement available.
  • Opportunity to engage in a safety-focused, compliance-oriented culture.
  • Involvement in cutting-edge biologics development and process enhancement.
  • Access to cross-functional collaboration, enhancing skill development and teamwork.
Full Job Description
Job Description

The Senior Specialist, Quality Assurance BDQR is responsible for providing Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring compliance with cGMPs, applicable worldwide regulations, and our Company requirements for supported area(s). The Senior Specialist applies a strong Quality mindset, partners with stakeholders, and supports compliant execution and decision-making across routine operations and quality events.

Primary Responsibilities include but are not limited to:
  • Provide Quality oversight and execute GMP/GxP quality assurance activities supporting manufacturing and testing operations, including material and batch documentation review and batch disposition.
  • Provide Quality oversight of an evolving biologics clinical space by identifying potential compliance risks, escalating issues as appropriate, and helping ensure compliant execution in fast-paced operational areas.
  • Support operational readiness by partnering cross-functionally to enable compliant start-up and execution of GMP activities.
  • Apply a quality-by-design mindset by supporting appropriate use of quality systems, procedures, and documentation controls through planning, execution, and routine operations.
  • Build and maintain effective partnerships with key stakeholders to provide Quality guidance, support timely decision-making, and contribute to oversight of quality events, including deviations, change controls, CAPA, and audit support.
  • Contribute to a culture of compliance and continuous improvement by supporting training expectations, audit readiness, and quality performance monitoring/metrics.
  • Remain informed of current GMP requirements and industry trends in the large molecule, analytical, and manufacturing areas to applicable worldwide regulations and industry standards. Maintain a proficient level of knowledge related to areas of technical expertise.
  • Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensuring periodic updates, as appropriate.
  • Manage the review and/or approval of analytical and process GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.
  • Act as Quality representative for internal or external manufacturing and testing of programs. Duties include compliance oversight of program-related activities, batch record review and approval, deviation and/or out-of-specification approval.
  • Represent the department or area on project teams establishing quality standards, policies or expectations within our Company.
  • Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements.
  • Provide quality oversight deliverables for large molecule drug substance analytical development and testing & release of clinical material.
  • Review and approve analytical and manufacturing documents.
  • Contribute to establishment and sustainability of a safety first, compliance always culture.


Education Minimum Requirement:

Bachelor's degree in science, engineering, or related discipline

Required Experience, Knowledge, and Skills:
  • Minimum of 5 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 3+ years with an advanced degree.
  • Experience in Biologics Quality, Biologics Manufacturing, and/or related functions at pilot and/or commercial scale.
  • Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
  • Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).
  • Demonstrated ability to manage projects and priorities to meet deliverables and timelines.
  • Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.


Preferred Experience and Skills:
  • Experience with quality risk management.
  • Experience supporting cross-functional teams and contributing to problem-solving situations.
  • Strong knowledge of biologics manufacturing processes, biologics analytical method validation and testing, and regulatory requirements.
  • Technical knowledge or proficiency in one or more elements of: GMP cleanroom facilities, electronic batch records, data integrity, SAP, automation, GMP operations in various product modalities or associated technologies.
  • Ability to identify, assess, and support resolution of complex problems in a timely and efficient manner.
  • Experience in facility start-up and GMP Operational Readiness or clinical supply areas and processes.


Required Skills:
Biopharmaceutical Industry, Deviation Management, GMP Compliance, Quality Assurance Systems

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
08/7/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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