Associate 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 interlinking global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Operations Laboratory is a 40,000 square foot facility that provides support to the Wilson plant site operations through raw material and finished product testing and release; additionally, the Laboratory supports our Company on a worldwide basis through performing stability testing on finished products and API's.

The Associate Specialist is an integral position for our worldwide Stability Laboratory that reports to the Stability Laboratory QA 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 the our Company guidelines.

Primary 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 Minimum Requirement

• Bachelor degree required (Science Degree, i.e. Chemistry, Biology, or Engineering) and one year of experience, or Associate degree and five years of experience, or High School Diploma/GED and five years of experience

Required Experience and Skills

• Minimum one year in the pharmaceutical industry

• Knowledge of cGMPs, NDA, related regulations

• Comprehension of documentation systems

• Strategic and effective communication both verbal and written

#WilsonQA

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 …

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