Quality Assurance Technician

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.

Description:

The Quality Assurance Tech position is available at our Animal Health facility in De Soto, Kansas, located near Kansas City metropolitan area. The DeSoto facility is expanding operations to manufacturing vaccines and biologics for large and companion animals. Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using fermentation and cell culture platforms, filling and packaging.

The basic purpose of this position is to provide Quality support for our company's Animal Health production site in De Soto, Kansas. This position assures that all specifications are met prior to release for compliance to product outlines, USDA 9CFR, and cGMP. The scope of support includes every manufacturing stage from raw material releases through final product packaging.

Duties and Responsibilities:

Quality Integrated Process Team (IPT) Representative

• Provide generalist Quality assistance directly to production
• Completion of quality checks and SAP transactions to disposition product
• Quality representative in daily Tier meetings

Deviation/Complaint/CAPA

• Author or participate in investigations for determination of root cause and impact assessment
• Completes CAPA as assigned

Change Control

• Completes change control action items as assigned
• 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 to Good Manufacturing Practices and established SOPs
• Resolves minor events identified through documentation review

Training

• Completes all training by assigned due date
• Cross train on other functions within the Quality Assurance department

Competencies:

• Ability to develop knowledge of quality systems to include Deviation, Complaint, Training, Audit/Inspection and Change Control
• Takes decisions with supervision by defined processes and the knowledge to escalate for review when required
• Developing problem-solving skills to identify logical solutions to challenges
• Ability to develop theoretical and practical knowledge of regulated processes such as 9CFR or Good Manufacturing Practice

Qualifications:

• High School diploma or equivalent required; Bachelor’s degree in scientific field preferred
• At least 2 years of experience in a quality, operational, or technical function assisting manufacturing of regulated product
• Exceptional organizational/communication skills and the ability to interact with diverse departments
• Excellent attention to detail
• Intermediate skills with Microsoft Office applications, inventory management programs, and databases
• Ability to utilize computing software systems for the creation, maintenance and tracking of product and quality system activities to assist monitoring & trending
• Technical writing skills to produce site documentation preferred

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 [email protected]
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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R91293