Merck Microbiology Lab Specialist, Quality Control in Elkton, Virginia
Are you interested in an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Quality Assurance 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.
Performs analytical testing in the Microbiology Quality Control laboratory on a variety of samples including drug substance, drug products, and/or incoming materials.
Prevalent techniques include Microbial Enumeration Testing, Endotoxin Testing, Sterility Testing, Bioburden Testing, Growth Promotion and others.
Ensures test data is accurate and all work is Right-First-Time.
Works closely with laboratory team members to ensure the highest levels of GMP compliance and inspection readiness.
Routinely participates in laboratory related activities such as second person review validation, qualification, report writing, deviation investigations, training, and others.
Must be able to work independently in an open team environment and have strong problem solving and communication skills.
This position will be responsible for assisting with laboratory GMP activities by performing instrument calibrations, instrument troubleshooting, laboratory atypical result investigations, inspection preparations (external agency, internal GMP, housekeeping}, manufacturing guideline compliance support, and sample flow management. Capable of interacting with and understanding various data acquisition/management software and Laboratory Information Management Systems.
Education Minimum Requirement:
- Bachelor’s in Microbiology, Biology, Biochemistry or other relevant discipline.
Required Experience and Skills:
Applicant must be able to work independently in an open and diverse team environment.
Time management and strong communication skills.
Strong problem solving and laboratory-related software application skills.
Preferred Experience and Skills:
Quality Control, Quality Assurance and/or cGMP experience.
A minimum of 2 years pharmaceutical /Microbiology testing experience.
Experience with Aseptic Technique
Experience with Sterility Testing
Experience with Endotoxin Testing
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
BSL 2 Lab
Number of Openings:
Requisition ID: R22372
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