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Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a \"Safety First, Quality Always\" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

* Under the supervision of the Quality Associate Director / Director, is responsible for laboratory technical support in the performance of wet chemical, instrumental, microbiological and physical analyses of in-process, intermediates and finished goods, raw materials, water and waste treatment samples.
* Responsible for laboratory operations including, validation/qualification of laboratory equipment and systems, conducting routine and non-routine maintenance, second person review of data, performing system administrator duties, develop and complete system life cycle documentation, leading laboratory deviations (root cause analysis, corrective action identification and deviation documentation), and timely method transfers and validations.
* Oversees testing activities within the laboratory section of their responsibility. Ensures compliance with GMP/GLP, and quality, safety and environmental policies and procedures. Ensures documentation is accurately completed and properly reviewed. May perform project work as assigned by the Quality Associate Director / Director.

Education Minimum Requirement:

* B.S. in Chemistry or equivalent science degree

Required Experience and Skills:

* Minimum of two years of relevant technical support experience.
* Has a good working knowledge of GMP's as they pertain to Active Pharmaceutical Ingredient manufacturing.
* Possess a sound Analytical background, including operation and troubleshooting of HPLC, GC, AA, FTIR and other laboratory instruments.
* Possesses strong problem solving skills, strong interpersonal skills, and the ability to work independently and with minimal supervision.

This position requires the following working conditions

* Working in the Quality group, you will be required to work with hazardous chemicals while wearing personal protective equipment.
* The site is a manufacturer of beta lactam antibiotics, and as a result, candidates must be able to work in and around the manufacturing and laboratory areas associated with such chemicals.

Preferred Experience and Skills:

* Ensures effective and timely deviation investigation closure; including, accurate root cause determination and implementation of effective solutions to prevent recurrences.
* Ensures compliance with quality, safety, and environmental policies and procedures. Ensures the laboratory area is maintained in good order at all times and follows up to ensure compliance issues are remediated.
* Ensures all members of the group are properly trained. Ensures all mandatory compliance and SOP training is completed in a timely manner and follows-up to ensure make-up training is received when necessary.
* Serves as System Administrator for various instrument systems and ensures appropriate documentation is maintained consistently with compliance requirements.
* Involved in writing protocols and execution of method validations and transfers, stability studies, and equipment/instrument qualifications.
* Knowledgeable in the Positive Performance Policies and manages employee performance, including adherence to work rules, attendance, tardiness. Ensures appropriate recognition is made for good performance and when warranted disciplinary actions are taken as necessary.
* Places a strong emphasis on effective communication. Meets regularly with the immediate work group, Manager, and customers being supported.
* Supports necessary aspects of internal GMP audits and monthly walk throughs as well as Agency Inspections.
* Provides review and revision of departmental procedures and test methods to ensure clarity, accuracy and GMP compliance.
* Involved in the purchase/installation/qualification of laboratory capital equipment.

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 ?

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as \"Merck\" in the United States, Canada & Puerto Rico. We are known as \"MSD\" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at ...@merck.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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Working in the Quality group, you will be required to work with hazardous chemicals while wearing personal protective equipment. The site is a manufacturer of beta lactam antibiotics, and as a result, candidates must be able to work in and around

Number of Openings:

1
Associated topics: assistant, client support, desk, excel, information technology help desk, information technology support, msword, support, technical support, technical support specialist

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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