New · posted Nov 12
Merck · Pharmaceuticals
Quality Assurance Specialist
- West Point, PA
- Hybrid
- Full-time
- Associate & Specialist
The role
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Quality Assurance Specialist (P2) is responsible for supporting Quality Systems processes related to Health Authority reporting, product complaint intake and assessment, adverse event management, and complaint sample coordination. This role ensures compliance with global regulatory requirements, internal quality standards, and company procedures for the timely evaluation, documentation, investigation, and reporting of product quality complaints and adverse events.
The successful candidate will serve as a key liaison between Quality Assurance, Pharmacovigilance, Manufacturing, Regulatory Affairs, and external stakeholders to ensure accurate complaint processing, effective sample management, and regulatory reporting activities.
In addition, responsible for carrying out divisional requirements as necessary. Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance.
What you need
Education Minimum Requirement
- Bachelor’s degree*. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
- * In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.
Required Experience and Skills
- Minimum three (3) years in Pharmaceutical Quality, Quality Assurance, Quality Systems, Product Complaints, Pharmacovigilance, or related experience with progressive and demonstrated Quality decision-making responsibility
- Experience working in a regulated GMP environment required.
- Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Deliver results across multiple functional areas at the site.
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
- Speaks with courage and candor
- Effective and positive written and verbal communication skills
- In-depth working knowledge and application of GMPs
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Required Skills
Audits Compliance, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance Tools, Quality Auditing, Quality Complaints, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management, Troubleshooting
Travel Requirements
10%
What you'll do
- Author Adverse Event Quality Investigation Reports
- Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples.
- Maintain complaint sample inventory and chain-of-custody records.
- Work with laboratories and investigation teams to ensure complaint samples are tested within established timelines.
- Ensure complaint samples are handled and retained according to GMP and company requirements.
- Support sample reconciliation activities and maintain accurate documentation.
- Author Health Authority responses and notifications
- Review and update procedures, work instructions, and training materials related to complaint handling and reporting processes.
- Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information
- Participates on teams supporting internal functions and/or evaluating site processes for improvement opportunities
- Provides information for regulatory inspections as requested
- Completes special projects or assignments as directed by management including conducting education and training on GMP requirements
- Individual may have the opportunity to support other areas within the West Point Quality Assurance organization, including:
- SOP and Batch Record Management
- Audits and Inspections
- Deviation Management
- Annual Product Reviews, Vendor Management
- Inspection Management, QMS/Quality Council Management
- Risk Management
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests
- Explains difficult issues and works to build alignment around a complex situation
- Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities
Pay and benefits
$87,000 – $137,000 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 and compassionate days
Annual bonus and long-term incentive eligibility
Where you'll work
West Point, PAHybridOpen in Maps (opens in a new tab)
More jobs in West Point, PAWorking 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
11/19/2026
*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 - Pennsylvania - West Point
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$87,300.00 - $137,400.00
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 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 33% above the US median for Complaints & Post-Market Quality roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $87,000 | — | $137,000 |
| All US (middle half) | $82,500 | $84,500 | $104,500 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Complaints & Post-Market Quality roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Complaints & Post-Market Quality
The general path across 29 open Complaints & Post-Market Quality 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 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA12
- GMP and compliance10
- Lab testing and methods9
- Documentation and SOPs8
- Collaboration and leadership8
- Quality systems and risk6
- Clinical trial conduct3
- Regulatory submissions2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Complaints & Post-Market Quality work in pharmaceuticals, led by the one 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
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- 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
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- 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
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 41
- Open roles
- 41
- Distinct roles
- 8
- Locations
By discipline
- Clinical26 63%
- Quality8 20%
- Regulatory7 17%
By level
- Director30 73%
- Senior & Principal7 17%
- Associate & Specialist3 7%
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Quality Assurance Specialist at Merck
Applications close November 19. $87K–$137K a year, employer provided.