Specialist, Quality Control

Job Description

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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Specialist position is responsible for providing project and technical support for the Chemistry Technical Support Services Team. A primary goal of this person is to provide excellent technical support to the Laboratory Operations area in support of schedule adherence, right the first time, and compliance (ex. deviation and change management) goals. The Specialist will support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories. Strong partnership with Laboratory Operations, Laboratory Quality Assurance, Divisional Analytical groups, and manufacturing areas is required.

The Specialist must be an advocate for maintaining a safe work environment and is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company's guidelines, policies and procedures.

This individual is expected to be proficient in NMR testing of raw materials / chemistry / biologics testing and to leverage this expertise to provide guidance for analytical changes, work standardization, and process improvements. The individual in this role will be responsible for driving and supporting projects, process improvements, as well as deviation and change management goals. The Specialist will utilize his / her communication skills to present complex concepts and results to diverse audiences.

Education Minimum Requirement:
  • Bachelor's Degree in Chemistry, Chemical Biology, or Biochemistry.
  • Master's Degree in Chemistry, Chemical Biology, or Biochemistry preferred.


Required Experience and Skills:
  • For candidates with a Bachelor's degree, a minimum of 3 years of experience in GMP Laboratory environment or related industry experience in a laboratory, manufacturing, science related or regulated setting.
  • For candidates with a Master's degree, at least 1 year of experience in GMP Laboratory environment or related industry experience in a laboratory, manufacturing, science related or regulated setting.
  • Experience using NMR systems and VNMRJ and TopSpin software is required.


Preferred Experience and Skills:
  • Thorough knowledge of NMR principles and troubleshooting.
  • Experience with analytical instrumentation (ex. MALLS, ICP, IC, UV, AA, and GC).
  • Experience using HPLC-MALLS systems and Astra software is preferred.
  • Experience using Dionex IC systems and Chromeleon software is preferred.
  • Experience using SAP, LIMS, and Trackwise.
  • Progressive and demonstrated Quality decision making responsibility.
  • Project Management, Change Execution Management and Team Leadership experience in a Quality function.
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
  • Proven analytical aptitude and critical thinking skills.
  • Demonstrated self-starter with capability to develop innovative solutions to challenges.
  • Strong written and verbal communication skills.
  • Comfortable with multi-tasking and working in a fluid environment.
  • In-depth working knowledge and application of GMPs/GLPs.
  • Experience in pharmaceutical laboratory operations or related environment.
  • Experienced investigator and the use of root cause analysis tools (E&CF, Fault Tree, Kepner-Tregoe).


Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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 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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Specified

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R79008