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 Sr. Tech., Quality Assurance position is available at our Animal Health facility in Worthington, Minnesota. The Worthington facility is expanding operations to manufacture vaccines for large and companion animals. Leveraging a skilled and innovative team environment, the key technologies at the site are biologics production using fermentation and cell culture platforms and filling and freeze-drying.

Under general supervision, this position assists in maintaining quality expectations and regulations for a biological vaccine manufacturing site in accordance with Good Manufacturing Practices (GMP) guidelines and site procedures.

Responsibilities:

* Review and release of incoming raw materials for use in production of biological vaccines, ensuring compliance with regulatory and site requirements for use.

* Coordinate with site stakeholders to maintain supply chain records, provide information for supplier audits, and manage incoming supplier change controls for site review.

* Reviews internal documents against regulatory requirements for accuracy and compliance.

* Use of electronic programs such as Word and Excel to create and maintain official controlled documents managed by the Quality Assurance (QA) department.

* General QA activities including but not limited to:

* Organization and filing of site documents,

* Maintenance of seed stocks

* Cleaning of QA areas

Education Minimum Requirements:

* High school diploma or GED with 6 years relevant work experience - OR - Associate degree in a related field with 4 or more years of experience - OR - Bachelor degree in a related field with 2 years relevant work experience

Position Qualifications:

* Ability to work successfully in a team-oriented environment and coordinate multiple tasks.

* Ability to work independently with minimal supervision

* Ability to effectively follow Standard Operating Procedures and other procedural guidelines.

* Strong organizational skills with close attention to detail.

* Strong computer skills with excellent communication and writing skills.

* Ability to convey information effectively with all levels of colleagues between multiple departments

Preferred Qualifications:

* Previous experience with USDA or EU GMP manufacturing and/or quality systems.

* Previous experience with inventory management systems; Systems Applications and Products (SAP) preferred.

* Knowledge of Lean process initiatives, 6-Sigma or similar programs.

* Ability to provide input on process related issues with a solid scientific foundation.

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:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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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 anothers 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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R107787