Job Description
The Quality Control Manager provides quality oversight of the qualified utilities and facility environmental monitoring sampling at the West Point vaccine manufacturing site. The Manager, with guidance from the Associate Director of Environmental Monitoring, ensures the qualified utilities (Water-for-Injection, Clean Steam, Compressed Gases) and Facility EM (Surface, Air, and Personnel Sampling), are being sampled as required and are operating in a state of environmental control. The Manager is responsible for the scheduling, review, and evaluation of testing data from qualified utilities and environmental monitoring. This position works closely with the vaccine manufacturing departments to ensure timely completion of tasks with emphasis on right first time.
The Manager will become knowledgeable in regulatory agency requirements and cGMPs to assure the qualified utilities and facility monitoring operate in a state of compliance and will train on and gain competency in their responsibilities.
Primary Responsibilities
Manage technicians performing sampling
Collaborates with shop steward and team lead to schedule testing and ensure timely and compliant sampling
Monitor testing performance against specifications
Provide support to manufacturing and laboratories as needed
Actively participates in meetings and escalates concerns and best practices
Collaborates with EM utility team and vaccine manufacturing in the identification and implementation of continuous improvement initiatives and action plans
Adherence to SOPs, GMPs, and safety procedures
Develop and manage SOP's, departmental project protocols and reports
Lead or contribute to key laboratory operations projects focused on compliance, capacity, demand management, assay performance, process improvement, and alignment with corporate goals.
Education Minimum Requirement
Bachelor's degree in biology, Engineering, Chemistry preferred, equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting
Required Experience and Skills
At least three (3) years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological/Analytical Laboratory Operations
Evidence of good verbal and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
Attention to detail, flexibility, and an awareness of production and associated quality control problems
Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical, or related fields
Preferred Experience and Skills
Managing/supervising teams
Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment
Effective problem-solving skills
Ability to manage multiple projects/tasks simultaneously
Required Skills:
Analytical Method Transfer, Analytical Testing, Analytical Thinking, cGMP Compliance, cGMP Regulations, Corrective Action Management, Deviation Management, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Instrumentation, Laboratory Information Management System (LIMS), People Management, Pharmaceutical Quality Control (QC), Quality Control (QC), Quality Standards, Technical Writing
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
The salary range for this role is
$96,200.00 - $151,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
08/28/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
