Manager, Quality Control

Merck & Co.

West Point (PA)

On-site

USD 96,000 - 151,000

Full time

4 days ago

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Benefits offered by this job

Medical

Dental

Vision & other insurance

401(k) retirement plan

Paid holidays

Vacation

Compassionate and sick days

Annual bonus and long-term incentive

Job summary

Merck & Co. in Rahway, NJ is seeking a Quality Control Manager to oversee environmental monitoring and qualified utilities at the West Point vaccine manufacturing site. You will schedule sampling, review data, and ensure compliance with regulatory requirements while supporting manufacturing and labs.

The role emphasizes right-first-time performance, regulatory knowledge, and collaboration across vaccine production teams to drive continuous improvement.

Qualifications

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
Attention-to-detail and understanding of GMPs/regulatory requirements

Responsibilities

Manage technicians performing sampling
Schedule testing to ensure timely and compliant sampling with shop steward and team lead
Monitor testing performance against specifications
Provide support to manufacturing and laboratories as needed
Participate in meetings and escalate concerns and best practices
Collaborate with EM utility team and vaccine manufacturing on continuous improvement initiatives
Adhere to SOPs, GMPs, and safety procedures
Develop and manage SOPs, project protocols and reports

Skills

Communication skills

Attention to detail

Verbal and written communication

Education

Bachelor's degree in biology, Engineering, Chemistry

Job description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a \"Safety First, Quality Always\" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

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

Preferred 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

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.

Equal Employment Opportunity

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

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.

Salary Range

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.

Benefits

medical

dental

vision healthcare and other insurance benefits (for employee and family)

retirement benefits, including 401(k)

paid holidays

vacation

compassionate and sick days

annual bonus and long-term incentive

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.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License