Assoc. Spclst, Quality Control
Assoc. Spclst, Quality Control
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Job Description
Job Description
Our Company is expanding its global vaccine production by adding an end to end laboratory capability located in the Durham NC campus. The facility will be used to produce the bulk active ingredient finished product.
The Associate Specialist Quality Control participates in a team of analysts in the development validation and routine testing. The position will focus on microbiology and sterility testing for commercial production. The successful candidate will work on assay development assay validation equipment validation and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples including bulk vaccine filled vaccine and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as sterility bioburden and endotoxin. The successful candidate will also be expected to review and authorize testing results collaborate in day-to-day lab scheduling provide leadership in lean lab initiatives have a strong understanding of Labware Laboratory Information Management System (LIMS) handle Quality Notification authoring and provide audit support.
Primary Responsibilities: The emphasis is on microbiological methods such as sterility endotoxin and bioburden.
Has knowledge of cell aseptic technique and standard microbiological procedures for BSL-1 and BSL-2 laboratories
Perform data review of laboratory test data and associated records
Trouble-shoots equipment issues as needed
Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions
Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements
Provides active support during audits and inspections (regulatory internal safety)
Supports our Companys Manufacturing Division (MD) divisional and Quality initiatives
Education Minimum Requirement:
B.S. degree in a science field required preferably biology microbiology or biological sciences
Required Experience and Skills:
Good technical writing skills and high attention to detail
One (1) year laboratory testing or equivalent educational laboratory
Work independently and within a team environment
Good communication
Aseptic techniques
Must be able to work the following schedule: Tuesday to Saturday or Sunday to Thursday 8-hour or 10-hour day shift weekend and holiday coverage schedule may vary.
Preferred Experience and Skills:
Knowledge of cGMP and cGDP
Experience handling and manipulating BSL-1 and BSL-2 microorganisms
Compendia microbiological testing methods
Bioburden testing
Endotoxin (LAL) testing
Growth Promotion
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:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - Day 2nd - EveningValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability Analytical Instrumentation Assay Bioburden Testing Biological Sciences Cell-Based Assays Chemical Analysis Data Analysis Finished Products GMP Compliance Laboratory Information Management System (LIMS) Laboratory Instrumentation Laboratory Techniques Microbiological Analysis Microbiological Cultures Microbiological Test Microbiology Teamwork Technical Writing Working IndependentlyPreferred Skills:
Job Posting End Date:
06/13/2025*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
