Job Description

Description:

The Quality Assurance Specialist for Batch Release is responsible for the execution of release tasks and preparation of documentation needed for the release of Final Product to market as well as supporting other Quality Assurance roles as needed. Specifically, the candidate would prepare submissions of 2008s for the USDA, complete release transactions within SAP as product is eligible for market, draft, review and approve supporting documentation (i.e., Certificates of Analysis, Test Reports, and Product Quality Reports).

All functions would be executed in compliance with internal standards, 9CFR regulatory guidelines, Outlines of Production and Special Outlines. Initiates, executes, and completes responsibilities per procedures and within Quality guidelines and communicates any compliance issues to managers. Additionally, this role will occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking, and creativity are necessary attributes for this role.

A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Duties & Responsibilities:

• Draft 2008 Test Reports for USDA Submission

• Complete Release Transactions in SAP

• Complete Country Release Transactions in SAP

• Prepare documentation accurately and per regulated procedures (i.e., Good Documentation Practices) including:

• Certificates of Analysis supporting release to Export Markets

• Test Reports for specific Export Markets

• Product Quality Reports for products made for the EU Market.

• Contribute to or Lead Department Investigations, as needed utilizing the Reliance Deviation Management System

• Manage Changes Records within the Reliance Change Management System

• Periodic review and revision of SOPs

• Participate in the sites Internal Audit Program

• Perform Finished Product Sampling as needed.

Required Skills & Experience:

• Demonstrated critical thinking skills.

• Experience in technical writing.

• Effectively communicate in a clear, concise, and appropriate manner.

• Effectively interacts with co-workers and others as needed. Demonstrates teamwork within own group and other groups.

• Troubleshooting / Problem solving skills.

• Use of Word and Excel, QM software for data management, MRP inventory software, and controlled document system. Additionally, Candidates have experience in SAP, Aera and Reliance or similar quality systems.

• Ability to lift up to 50 lbs.

Education Requirements:

• High School diploma with at least 2 years relevant experience

• Degree preferred (Associates or higher) in a scientific discipline.

Preferred Experience and Skills:

• Experience in Quality Control or Quality Assurance

• Familiar with USDA 9 CFR regulations.

• Animal Vaccine Manufacturing experience

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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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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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:

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Requisition ID:R314206