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Merck Associate Specialist, Quality Assurance in De Soto, Kansas

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

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 basic purpose of this position is to provide quality support for our Company Animal Health production site in De Soto, Kansas. This position assures that all specifications are met prior to release for compliance to product outlines, United States Department of Agriculture 9 Code of Federal Regulations, and cGMP. The scope of support includes every manufacturing stage from raw material releases through final product packaging.

Responsibilities

Quality Integrated Process Team (IPT) Representative

  • Provide generalist Quality support directly to production

  • Completion of quality checks and SAP transactions to disposition product

  • Quality representative in daily IPT Tier meetings

  • Collaborates with IPT members in the identification and implementation of continuous improvement actions

Deviation | Complaint | CAPA

  • Author or participate in investigations for determination of root cause and impact assessment

  • Assess, review, and area approve assessment of impact to recommend disposition of any impacted products

  • Completes Corrective Action and Preventive Action as assigned

  • Performs follow up for Corrective Action and Preventive Action completion

Change Control

  • Support, track and assure completion of change control documentation

  • Completes change control action items as assigned

  • Conducts review and approval of change controls as a subject matter expert in Quality Assurance

  • Conducts review and approval of significant change controls as applicable for assigned area

  • Revises existing documents and procedures

  • Creates new documents

Documentation Review | Approval

  • Preparation and review of APHIS Form 2008 for submission to USDA for serial release

  • Preparation and review of export documentation such as Certificates of Analysis

  • Documentation review for compliance with Good Manufacturing Practices and established SOPs

  • Resolves minor events identified through documentation review

  • Serves as documentation SME, provides coaching and mentoring of manufacturing managers and operators completing documentation

Training

  • Completes all training by assigned due date

  • Cross-train on other functions within the Quality Assurance department

  • Assist with the development of training plans

Audits/Inspection

  • Participates in audits and inspections as assigned (subject matter expert, reviewer, scribe, runner, preparation team)

  • Trending and monitoring of Quality metrics

Education Requirements

  • Bachelor degree in a scientific field with two years of relevant experience

Experience and Skills

Required

  • Minimum two years in a quality, operational, or technical function supporting manufacturing of the regulated product

  • Working knowledge of quality systems to include Deviation, Complaint, Training, Audit/Inspection, and Change Control

  • Efficient and effective organizational/communication skills and the ability to interact with diverse departments

  • Makes decisions with minimal supervision by defined processes and the knowledge to escalate for management review

  • Exceptional problem-solving skills to identify logical solutions to challenges

  • Excellent attention to detail

  • Strong technical writing skills to produce site documentation

  • Ability to utilize computing software systems for the creation, maintenance, and tracking of product and quality system activities to support monitoring & trending

  • Intermediate skills with Microsoft Office applications, inventory management programs, and databases

  • Understanding root cause investigation process, statistical quality control techniques, and continuous process improvement

Preferred

  • Strong theoretical and practical knowledge of regulated processes such as 9CFR or Good Manufacturing Practice

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

No Travel Required

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R150844

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