Assoc. Spclst, Quality Control
Assoc. Spclst, Quality Control
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Job Description
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
Bachelors 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
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 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:
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 anothers 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 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
$63900.00 - $100500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability Adaptability Analytical Instrumentation Analytical Method Development Analytical Problem Solving Assay Bioburden Testing Biochemical Assays Biochemistry Chemical Analysis Data Analysis Environmental Monitoring GLP Regulations Immunochemistry Immunology Karl Fischer Titrations Laboratory Instrumentation Laboratory Techniques Management Process Microbiological Cultures Microbiological Test Microbiology Microbiology Research Molecular Microbiology Quality Control Management 4 morePreferred Skills:
Job Posting End Date:
07/24/2025*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.
Employment Type
Full-Time
