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Job DescriptionOur Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.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, bacteriostasis/fungistasis, Neomycin potency, Mycoplasma, and Mycobacteria.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 understand of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support.Primary Responsibilities
Schedule daily testing of laboratory samples based on internal metrics and production needs
Serve as a Microbiology subject matter expert for internal and regulatory inspections
Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness
Train and mentor laboratory analysts on microbiological test methods, techniques and good documentation practices
Author and execute test method qualifications and final reports for microbiological assays
Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures
Authors Standard Operating Procedures (SOPs) for the performance of laboratory methods
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 Manufacturing Division divisional and Quality initiatives
Education Minimum Requirement
Bachelor degree in scientific discipline
Required Experience and Skills
Minimum two (2) years of related experience
Knowledge of cGMPs
Root cause analysis methodology
Compendia microbiological testing methods
Analytical method transfer
Sterility testing
Mycobacterium/Mycoplasma testing
Growth Promotion
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 .INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn 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.Secondary Language(s) Job Description·US and Puerto Rico Residents Only:If you need an accommodation for the application process please email us at staffingaadar@msd.comFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdfEEOC GINA Supplement at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:Not SpecifiedShift:1st - DayValid Driving License:YesHazardous Material(s):Standard laboratory chemicalsNumber of Openings:2Requisition ID: R59364
