Job Description

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 Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product/process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system. He or she provides Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls.

The Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. Job functions are performed primarily on the production shop floor and in a team environment.

Responsibilities

* Performs batch release of products he or she supports

* Collaborates with Planning, Operations, and Technology organizations to ensure batches are ready for release by appropriate due dates

* Assists in sending samples/lab reagents to release authorities

* Completes required SAP transactions to release product in SAP

* Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material as required

* Completes, reviews, and sends release protocols to regulatory agencies

* Supports Regulatory inspections. Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors

* Provides coaching and mentoring of manufacturing supervisors and operators

* Performs Quality review/approval of new and updated SOPs and CJAs

* Assists with training of incoming personnel, and ensures compliance with departmental procedures

* Actively participates in the Tier process and uses this forum to escalate concerns and best practices

* Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans

Education Requirement

Bachelor degree in a scientific or engineering field (preferred) | Candidates with degrees in other fields will be considered if accompanied by significant relevant experience

Experience and Skills

Required

* Three years of relevant post-degree work in a laboratory, manufacturing, or quality position

* Evidence of leadership skills coupled with effective verbal and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills

* Attention to detail, flexibility and an awareness of production and attendant quality control problems

* Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area

Preferred

* Familiarity with vaccine and/or pharmaceutical processing

* Familiarity with release of product, deviation management and change control is a key skill necessary for success in this position

* Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas

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:

Travel Requirements:

Flexible Work Arrangements:

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R101959