New · posted Nov 13
Merck · Pharmaceuticals
Senior Specialist, Quality Assurance - 3rd Shift
- Rahway, NJ
- On-site
- Full-time
- Senior & Principal
The role
The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. They independently perform review and routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures, Good Manufacturing Practices and other applicable worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notify relevant management of unresolved issues/trends.
Notice
The position will initially be assigned to 1st shift (e.g., 8:00 AM–4:00 PM) or 2nd shift (e.g., 4:00 PM - 12:00 AM) initially for training purposes. The position will be expected to transition to 3rd shift (e.g., 12:00 AM –8:00 AM) once training is complete. Applicants should be willing and able to accept a schedule change at that time and thereafter, to work either shift. Reasonable notice of schedule changes will be provided.
What you need
Education Minimum Requirement
- B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology).
Required Experience, Knowledge, and Skills
- 5 years of experience in the pharmaceutical or related industry
- Understanding of current Good Manufacturing Practices and Good Documentation Practices and related drug regulation requirements, including European Union.
- Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development
- Attention to detail, flexibility, and an awareness of production and associated quality problems.
- Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.
- Demonstrated ability to manage multiple projects and priorities simultaneously, and to meet deliverables and timelines.
Required Skills
Continuous Improvement, Good Documentation Practices, Good Manufacturing Practices (GMP), Quality Assurance (QA), Standard Operating Procedure (SOP)
Travel Requirements
No Travel Required
Preferred Experience and Skillsnice to have
- Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.
- A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.
- Experiences in a Good Manufacturing Practice environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
- Ability to identify, focus, and solve problems in a timely and efficient manner.
- Experience with quality audits and EU regulatory inspections.
- Experience with Data Integrity and speak-up culture
- Experience or working knowledge of R&D or clinical supply areas and processes.
What you'll do
The Specialist will become knowledgeable in regulatory requirements, Good Manufacturing Practice and company procedures to assure clinical drug product manufacture is compliant and will gain competency in their responsibilities. Primary responsibilities include but are not limited to the following:
- Perform Good Manufacturing Practice documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.
- Accountable for all assigned projects and communication of status to the Management team.
- Identify need for and/or develop Standard Operating Procedures to ensure practices are accurately reflected. Assist in Standard Operating Procedures and quality-related system development and approval.
- Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current Good Manufacturing Practice posture within Global Development Quality.
- Adhere to Good Manufacturing Practices and Standard Operating Procedures
- Identify and implement continuous improvement initiatives and action plans.
- Assist in preparations for regulatory agency inspections.
- Ensure procedures are followed and specifications met to release or reject materials.
- Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
- Establish, educate, and enforce standard operating procedures required under Good Manufacturing Practice.
- Participate in investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
- Maintain a state of readiness for and participate in audits and inspections.
- On-site support of production facility & staff
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
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
Rahway, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Rahway, NJWorking conditions
3rd - Night
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/20/2026
*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 · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 39% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US24 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $106,000 | — | $167,000 |
| All US (middle half) | $94,875 | $98,000 | $123,750 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 109 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Documentation and SOPs10
- Lab testing and methods6
- Collaboration and leadership5
- Investigations and CAPA3
- Quality systems and risk3
- Clinical trial conduct2
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
Company hiring pulse
Merck on Regulatory Jobs
- 31
- Open roles
- 31
- Distinct roles
- 7
- Locations
By discipline
- Clinical18 58%
- Quality7 23%
- Regulatory6 19%
By level
- Director21 68%
- Senior & Principal7 23%
- Associate & Specialist2 6%
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Senior Specialist, Quality Assurance - 3rd Shift at Merck
Applications close November 20. $106K–$167K a year, employer provided.