Job Description

Job Description

The Specialist is an integral position for our worldwide Stability Laboratory that reports to the Stability Laboratory Manager. The position is accountable for management of stability samples for the site stability program and for external sites that send samples to NASU-Wilson to be placed on stability. Accountable for establishing stability studies, placing samples in chambers and pulling stability samples for laboratory testing within the required time frames set forth in our Company guidelines

Responsibilities

* Receives annual stability plan from other sites and ensures that stability samples and related documentation are received accordingly

* Accountable for management of projects, obtaining stability samples and starting stability studies

* Provides API sample material, labels and documentation to API chemists for subdivision

* Accountable for writing study protocols based on the General Stability Protocol

* Removes extraneous secondary packaging on samples as needed; prepares and affixes stability sample labels on samples, stores samples in stability chambers and records inventory information in LIMS

* Maintains stability sample inventory information in SQL/LIMS | Discards samples for concluded and terminated studies

* Creates, updates and maintains stability study files

* Develops/revises SOPs based on our Company policies/guidelines

* Assists with laboratory investigations and integrates appropriately personnel into investigation meetings to determine root cause and path forward

Education Requirement

* Bachelor degree (Science Degree, i.e. Chemistry, Biology, or Engineering)

Experience and Skills

Required

* Minimum three years pharmaceutical industry

* Knowledge of cGMPs, NDA, related regulations

* Comprehension of documentation systems

* Strategic and effective verbal and written communication

Preferred

* Flexibility

* Motivation

* Functional excellence

* Teamwork/Partnership

* Results-Oriented

* Problem-Soving

* Communication

WilsonQuality

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 thats 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:

Flex Time

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Yes - OEB 3, 4, 5 compounds

Number of Openings:

1
Requisition ID:R103481