New · posted Oct 14
Merck · Pharmaceuticals
Senior Specialist, Quality Assurance
- Rahway, NJ
- Hybrid
- Full-time
- Senior & Principal
Closes Oct 20, 2026 · 7 days left
The role
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.
What you need
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.
Required Skills
Audits Compliance, CAPA Management, Deviation Management, GMP Auditing, Manufacturing Processes, Operational Compliance, Operational Quality, Quality Assurance Processes, Quality Assurance Systems, Quality Risk Management
Travel Requirements
10%
Preferred Experience and Skillsnice to have
- 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.
What you'll do
- 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.
Pay and benefits
$106,000 – $167,000 a year
Employer providedAdditional location(s) Compensation Information
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Medical, dental and vision insurance
Retirement benefits including 401(k)
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
Rahway, NJHybridOpen in Maps (opens in a new tab)
More jobs in Rahway, NJWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
Job Posting End Date
10/20/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$106,200.00 - $167,200.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in New Jersey11 roles publishing pay
Senior & Principal roles in the US221 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $106,000 | — | $167,000 |
| New Jersey (middle half) | $101,000 | $130,000 | $143,000 |
| All US (middle half) | $105,500 | $124,500 | $142,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 598 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance16
- Lab testing and methods8
- Documentation and SOPs7
- Collaboration and leadership7
- Quality systems and risk5
- Investigations and CAPA3
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
Company hiring pulse
Merck on Regulatory Jobs
- 22
- Open roles
- 22
- Distinct roles
- 6
- Locations
By discipline
- Regulatory13 59%
- Quality8 36%
- Compliance & Safety1 5%
By level
- Senior & Principal9 41%
- Director7 32%
- Associate & Specialist6 27%
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Senior Specialist, Quality Assurance at Merck
Applications close October 20. $106K–$167K a year, employer provided.