New · posted Nov 5
Merck · Pharmaceuticals
Specialist, Operational Quality Control
- West Point, PA
- On-site
- Full-time
- Associate & Specialist
The role
The Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. This role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, and company quality standards. The incumbent will support routine and non-routine Micro Sterility Assurance testing activities, review documentation for accuracy and completeness, and partner with laboratory and quality teams to drive continuous improvement. In addition, this position will support process improvement initiatives through MPS, helping identify opportunities to improve efficiency, compliance, and operational performance.
The Quality Specialist is expected to maintain a strong understanding of GMP, SOPs, deviations, and other quality system requirements, while ensuring work is completed accurately, consistently, and in compliance with regulatory expectations.
What you need
Required Skills
Adaptability, Analytical Instrumentation, Analytical Method Development, CAPA Management, Continuous Improvement Techniques, Deviation Management, Deviation Reporting, Driving Continuous Improvement, GMP Compliance, Good Lab Practices, Inspection Readiness, Laboratory Analysis, Laboratory Documentation, Laboratory Quality Control, Laboratory Safety, Microbiological Analysis, Quality Assurance (QA), Quality Improvement, Quality Metrics, Sterility Assurance, Teamwork, Technical Writing, Trend Monitoring, Troubleshooting, Use of Laboratory Equipment
- Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline preferred.
- 1+ years of experience in a GMP-regulated environment, preferably in a microbiology or sterility assurance setting.
- Working knowledge of SOPs, deviations, investigations, and quality systems.
- Experience supporting laboratory testing and documentation review.
- Familiarity with continuous improvement tools and MPS principles preferred.
- Strong attention to detail, organizational skills, and analytical thinking.
- Effective communication and collaboration skills.
- Ability to work independently and within cross-functional teams.
Travel Requirements
No Travel Required
Preferred Skillsnice to have
- Experience in sterility assurance, microbiological testing, or quality assurance laboratory support.
- Understanding of CAPA, change control, and audit readiness processes.
- Ability to support process improvement and standardization efforts.
- Strong problem-solving mindset and commitment to compliance.
The role is part of a 7-day operation and may require flexibility to support business and laboratory needs.
What you'll do
- Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
- Support Micro sterility assurance testing processes in accordance with GMP, SOPs, and applicable quality standards.
- Review laboratory documentation, records, and data for accuracy, completeness, and compliance.
- Assist in deviation investigation, documentation, and follow-up actions.
- Support quality system activities including change control, documentation review, and CAPA where applicable.
- Partner with laboratory staff and quality representatives to ensure compliance and timely resolution of quality issues.
- Contribute to process improvement initiatives using MPS to improve laboratory efficiency, standardization, and compliance.
- Participate in root cause analysis and problem-solving activities related to laboratory quality events.
- Ensure adherence to data integrity, documentation practices, and good laboratory practices.
- Support internal audits, inspection readiness, and other quality-related assessments as needed.
- Monitor trends, identify recurring issues, and recommend corrective and preventive actions.
- Assist with the implementation and maintenance of quality metrics and continuous improvement plans.
- Participate in daily tier meetings to review priorities, escalate issues, track action items, and support timely resolution of operational and quality concerns.
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 days
Annual bonus and long-term incentive eligibility
Where you'll work
West Point, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in West Point, PAWorking conditions
1st - Day
Hazardous Material(s)
Yes
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/12/2026
*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 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 53% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $87,000 | — | $137,000 |
| All US (middle half) | $66,000 | $73,000 | $81,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 55 open Microbiology & Sterility Assurance 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 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods15
- GMP and compliance12
- Documentation and SOPs10
- Quality systems and risk10
- Investigations and CAPA7
- Collaboration and leadership5
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance 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
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- 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
- 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
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- 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
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Merck on Regulatory Jobs
- 40
- Open roles
- 40
- Distinct roles
- 7
- Locations
By discipline
- Clinical29 73%
- Quality6 15%
- Regulatory5 13%
By level
- Director29 73%
- Associate & Specialist5 13%
- Senior & Principal4 10%
More roles at Merck
- View role
Senior Director, Clinical Science, Immunology
Rahway, NJ · HybridDirectorPharmaceuticals$210K–$331K
- View role
Clinical Director, Clinical Research, Hematology
Rahway, NJ · HybridDirectorPharmaceuticals$256K–$403K
- View role
Senior Clinical Director, Clinical Research, Hematology
Rahway, NJ · HybridDirectorPharmaceuticals$282K–$444K
- View role
Senior Director, Clinical Science, Pulmonary Hypertension and Cardiovascular
Rahway, NJ · HybridDirectorPharmaceuticals$210K–$331K
Similar Microbiology & Sterility Assurance roles elsewhere
- View role
Quality Control Microbiology Specialist
GSKKing of Prussia, PAAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
Quality Lab Analyst I
BaxterMarion, NCAssociate & SpecialistPharmaceuticals$68K–$94K
- View role
Quality Lab Associate I, Microbiology
BaxterRound Lake, ILAssociate & SpecialistPharmaceuticals$68K–$94K
- View role
Microbiologist II - Quality Control
PadagisMinneapolis, MNAssociate & SpecialistPharmaceuticalsSalary not listed
Specialist, Operational Quality Control at Merck
Applications close November 12. $87K–$137K a year, employer provided.