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

The Specialist, Quality Control requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems. Analyzes possible solutions using standard procedures. Builds knowledge of the company, processes, testing and customers. Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions. Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals. Demonstrates a deep understanding of customer needs, requirements, and expectations. Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory. Speaks up on tough issues and occasionally challenges the status quo. Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas. Works to develop new skills and abilities. Readily accepts performance feedback and incorporates this feedback into future performance. Assists other team members, including helping with developmental activities. Learns to use new problem-solving tools to surface and solve issues. Good organizational and time management skills. Assists in direction of plant wide or department objectives.

Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory. Ability to interpret our Company Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses an expanded knowledge of theories, practices, and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing. Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc. Possesses an advanced knowledge and ability to operate multiple instruments required to complete job responsibilities with the ability to generate data and reports from these instruments. Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures. Ability to objectively respond to advanced requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change. Explains information and persuades others in straightforward situations. Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others. Makes decisions within guidelines and policies that impact own priorities and allocation of times to meet deadlines. Recommends scientifically sound corrective and preventive actions. Accountable for technical contribution to work or project team and may lead or manage a small project team.

Primary Responsibilities

* Completes a variety of testing to support release and stability requirements for a variety of products

* Supports all areas of the laboratory, cross-training and providing testing support in various work cells as required

* Provides training to other teammates and serves as subject matter experts

* Works with other company sites to ensure delivery schedules of samples to be tested are met

* Maintains compliance by following corporate policies/guidelines and local procedures

* Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activities

* Identifies and implements changes focused on improving compliance performance in the laboratory

* Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell and actively participates in Tier II and, as needed, Tier III as needed

* Demonstrates in-depth understanding of product performance and testing methodology

* Able to train others on both and promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example

* Identifies proactive measures to ensure right first time achievement

* Leads remediation of walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits

* Works cross functionally to ensure proper prioritization/effective utilization of laboratory equipment

* Tests and interprets results for components, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples

* Interprets compendial and internal monographs, NDAs, CFR and our Company Quality Standards

* Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations

* Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements

* Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.)

* Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory

* Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance

* Provides guidance and coaching to new analysts within and outside his/her cell. Performs any other work as assigned by Manager

Education Minimum Requirements

* Bachelor of Arts or Science degree (preferably in Science or Engineering)

Required Experience and Skills

* 2+ years demonstrated knowledge of continuous improvement principles

* 2+ years operating routine laboratory equipment including but not limited to: HPLC, Karl Fisher, Drug Dissolution, pH meter, etc.

* Knowledge of regulatory and cGMP principles

Preferred Experience and Skills

* Utilizing Empower and LIMS

* Implementation of root cause analysis

* Knowledge of Tier process

* 5S principles

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 thats 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
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:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Number of Openings:

1
Requisition ID:R84595