Job Description
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.
Additional Responsibilities
General
- Conducts release testing in support of finished product, including sterility testing, detection of residual moisture, average cell dry weight testing
- Conducts microbiological testing; evaluation of environmental microbiological samples
- Conducts environmental monitoring sampling to include active air and surface sampling and water sampling
- Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects
Business & Functional Expertise
- Completes assignments in alignment with department objectives
- Conducting In-Process and Release testing
- Conducting Environmental Monitoring of processes and on a routine basis
Problem Solving
- Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head
Impact Influence
- Communicates information, asks questions and checks for understanding
Accountability
- Accountable for own performance
Decision Making
- Makes decisions – guided by policies and procedures – on the shop floor
- Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes
Shift
1st Shift Days - Weekends Required (Sun-Thu or Tue-Sat)
Education/Experience Requirements
- Bachelor's degree in Biology, Microbiology, Biochemistry, or related field
- Minimum 1 year of experience in the pharma or related industry.
Required Experience and Skills
- Understanding and application of Good Laboratory Practices and cGMPs
- Aseptic technique
- Performance of environmental and water systems monitoring
- Working in a team environment
Preferred Experience and Skills
- Strong verbal and written communication skills
- Experience with LIMS, SAP or other laboratory/production software systems
Working Relationships
- Reports to Quality Control manager
- Interacts with employees within own department and other departments
VETJOBS #EBRG
Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Biochemistry, Biopharmaceutical Industry, Chemical Analysis, Data Analysis, Environmental Monitoring, Global Manufacturing, Immunochemistry, Karl Fischer Titrations, Laboratory Instrumentation, Laboratory Techniques, Microbiological Test, Microbiology, Microbiology Research, Molecular Microbiology, Quality Assurance (QA), Quality Control Management, Report Writing, Teamwork, Technical Transfer {+ 2 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
The salary range for this role is
$65,100.00 - $102,500.00
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:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
Yes
Job Posting End Date:
08/5/2026*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: R409682
