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QC Microbiology Specialist (Millsboro, DE)

Merck


Location:
Millsboro, DE
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
QUA006133
Merck
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Job Details

Job Title: QC Microbiology Specialist (Millsboro, DE)  - QUA006133

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 

 

Merck Animal Health, Millsboro, DE is a Bio-Technology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.  Our site is responsible for mammalian, insect and avian cell culture production, live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production and down-stream processing (water in oil emulsions, aseptic filling, lyophilization, etc.)

The QC Microbiology Specialist, with Guidance from the QC Manager, ensures product/process quality through the oversight of the QC Microbiology program, including the

Responsibilities:

 

• Demonstrates, at all times, safe work habits and maintains a safe work environment.  Understands and complies with all safety and company policies and procedures.

• At all times follow Good Manufacturing Practices, Quality Control Procedures (QCPs), Standard Operating Procedures (SOPs), and adhere to all safety and company policies, perform duties assigned by department management.

• Daily inter-departmental interactions and communications, as liaison for Quality Control, including the training of technicians on microbiology and aseptic technique.

• Maintain identification program of microbial isolates from environmental monitoring and product related testing.

• Responsible for maintaining environmental isolate library, and growth promotion program.

• Implementation, revision of, and performing testing described in QC SOP and other procedures.

• Along with EM coordinator, track and trend EM data, with focus on microbial organism trending. This includes the preparation of analytical reports, trend analysis reports and summaries as required.

• Initiate, investigate and write deviations, change controls, out of specification (OOS), out of trend (OOT)

• Act as microbiology subject matter expert for site investigations.

• Drive process improvement using Six Sigma and MPS tools.

• Participation in project teams and/or complete design of special projects.



Qualifications

Education Minimum Requirement:
Minimum of a BS in Microbiology is required


Required Experience and Skills:


•Minimum of 5 years of experience in GMP environment, Pharmaceutical/Biological Quality or Technical function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
• Must possess thorough knowledge of the underlying principles used in testing procedures and understand the material being evaluated, i.e. virus, bacteria, cell line, etc.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
• Demonstrated strength in communication, both written and verbal, with proven leadership skills and training experience.
• Proven ability to effectively manage multiple and changing proprieties and projects and ensure timely completion.
• Ability to work well independently, as well as part of a team.
• Demonstrated experience with aseptic technique


Preferred Experience and Skills:


• Experience in cleanroom environment
• Knowledge and understanding of cGMPs, USDA, EU, and other regulatory requirements
• MPS, KATA, 5S experience
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Quality Lab Related

Primary Location NA-US-DE-Millsboro

Other Locations 

Employee Status Regular

Number Of Openings 1

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