Job Description
The Laboratory Operations Quality Specialist- AVS provides quality oversight of the Airflow Visualization Studies at the West Point vaccine manufacturing site. The Specialist, with guidance from the Associate Director of Environmental Monitoring Site Support, ensures AVS are performed per the required schedule; meeting the necessary acceptance criteria. The individual will be responsible for scheduling, written documentation, video recording, and video editing of the studies. This position works closely with the vaccine manufacturing departments and Engineering/Maintenance to ensure timely completion of tasks with emphasis on right first time.
The specialist will become knowledgeable in regulatory requirements and cGMPs to assure the AVS are executed according to requirements and gain competency in their responsibilities. Specific responsibilities include but are not limited to the following:
- Aseptic Gowning
- Working relationship with IPTs
- Strong understanding of aseptic technique and first air principles
- Video editing and storing of video evidence per data integrity requirements
- Recording video in Grade A areas
- General knowledge of computers and technology
- Mange SOP updates
- Author protocol and reports, memos, and annual evaluations
- Provide support to manufacturing and laboratories as needed.
- Identify and implement continuous improvement initiatives and action plans.
- Adherence to SOPs, GMPs, and safety procedures
Note: In this position the individual will be required to move large Dewars (>50 pounds) of N2, hold a video camera or fogger apparatus for long periods of time
Education Minimum Requirement: - Bachelor's degree required. Biology, Engineering, Chemistry or related field is preferred.
Required Experience and Skills: - Evidence of good oral 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 problems.
- Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical, or related fields.
Preferred Experience and Skills: - Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment.
- Strong problem-solving skills.
- Demonstrated ability to manage multiple projects/tasks simultaneously
VETJOBS
Required Skills: Adaptability, Adaptability, Aseptic Manufacturing, Aseptics, cGMP Compliance, Computer Information, Computer Technology, Continual Improvement Process, Data Analysis, Decision Making, Documentation Review, Documentations, Environmental Monitoring, Environmental Monitoring Systems, FDA Regulations, GMP Compliance, Immunochemistry, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Management Process, Problem Solving Therapy, Quality Inspections, Quality Operations {+ 5 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
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:
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
U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$85,600.00 - $134,800.00
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: 10%
Flexible Work Arrangements: Not Applicable
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 10/30/2025
*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: R364601
Job Tags
Full time, For contractors, Work at office, Local area, Remote work, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,