Specialist, Operational Quality Control

Job Description

Position Overview

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.

Essential Functions

• 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.

Qualifications

• 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.

Preferred Skills

• 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.

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

Preferred Skills:

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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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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.

Additional 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

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Yes

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.

Requisition ID: R424775