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 delivering 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.

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

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

• Performs 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 and Experience Minimum Requirement:

• High school diploma or equivalent required. Bachelor's degree in a scientific field preferred.

• Two (2)+ years of experience in a quality, operational, or technical function supporting manufacturing of the regulated product required.

Required Skills and Experience:

• Must have a working knowledge of quality systems to include Deviation, Complaint, Training, Audit/Inspection, and Change Control

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

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

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

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

• 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

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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.

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.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:R205481