Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Under the general direction of the Director, Wilson Quality Operations, the Associate Specialist is responsible for the following (but not limited to):
Qualification, routine and per process monitoring of the facilities, utilities and personnel
Trending for Utility Systems and Classified Areas including evaluating data for adverse trends
Collection and submission of samples in GLIMS
Authoring of investigations and implementation of appropriate corrective/preventative actions
Assist with protocol development and execution of the Process Simulation program
Adherence to departmental Quality metrics
Provide Shopfloor support and review of batch generated documentation
Performs other duties as assigned
Primary Activities include, but are not limited to:
Specific to Environmental and Utility Monitoring, this position will be responsible for maintaining the EM program to include the following:
Directly support performance qualification activities
Collection of utility systems samples including water, clean steam, and clean dry air
Execute environmental sampling of classified areas including active viable air, non-viable air, and surface sampling
Compile and author annual reviews
Provide data entry, review, and approval as required in GLIMS
Provide summaries of test results to appropriate personnel as necessary
Compile and evaluate environmental monitoring data for adverse trends
Conduct investigations for deviations and Out of Specification results Interprets our company's Quality policies, GMPs and other agency regulations for application to Wilson Operations
Specific to Quality Operations, this position will be responsible for, but not limited to the following:
Identifies and implements continuous improvement activities
Batch documentation review and/or approval
Provide shopfloor support, through aseptic observations or other observations, during operations
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
Schedule: 11:00 pm to 7:00 am Mon -Fri
Education Minimum Requirement:
Must possess at a minimum an associate degree or equivalent experience in the pharmaceutical industry
Required Experience and Skills:
Must possess a minimum of one (1) year of GMP pharmaceutical industry experience.
Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Ability to perform routine assignments and develop competence by performing structured work assignments.
Ability to use existing procedures to solve routine and standard problems.
Promotes the team's effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.
Readily accepts performance feedback and incorporates this feedback into future performance.
Ability to interpret our company's Quality Policies, Procedures and Guidelines for daily application.
Ability to independently respond to basic requests for data and trending of data.
Willing to work irregular hours to support multi-shift operation on an as needed basis
Preferred Experience and Skills:
GLIMS experience preferred
Experience with aseptic filling, environmental monitoring and process simulations.
Ability to learn new processes and computerized systems with limited support.
Experience in continuous improvement, LEAN manufacturing, problem solving, and/or Right First Time methodologies.
Strong written and verbal communication skills including technical writing experience with investigations, change requests, standard operating procedures, protocols, etc.
VETJOBS
MSJR
Required Skills:
Aseptic Filling, cGMP Compliance, Deviation Management, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Technical Writing, Test and Evaluation (T&E)
Preferred Skills:
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
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/)
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
$71,900.00 - $113,200.00
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 https://jobs.merck.com/us/en/compensation-and-benefits .
You can apply for this role through https://jobs.merck.com/us/en (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:
3rd - Night
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
03/19/2026
*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: R387607
