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Job Description

Associate Specialist, Quality Assurance Release

Position Description:

This role will support Quality Assurance team by coordinating, creating, and submitting 2008s to USDA for all serial batches produced at DeSoto. This Quality Assurance colleague will collaborate with Supply Chain, Manufacturing, Packaging, Quality Control and Quality Assurance to ensure timely release of FPP, FPU and antigens to meet production schedules and customer demand.

Primary responsibilities include:

• USDA Form 2008 generation and submission via USDA Portal for all serial batches.

• Formulating and submitting audit response for any audited serials.

• Apply material control for all components after deviation closure and to complete Usage decision in SAP for materials that are associated with deviations.

• Secondary Point of contact and supporting Supply Chain regarding serial release.

• Release all FPU-L serials (Filled Product that are labelled).

• Participating in material review board meeting to ensure all blocked materials are released in a timely manner.

• Updating 2008 tracker, LROTS tracker to maintain the status of the materials to ensure timely release.

• Creation and verification of Certificates of Analysis (CoAs) and Expiration dates for serials.

• Update / create relevant SOPs as needed.

• Proficient in using Deviation management / change management systems.

• Pick up QC test records and maintain filing.

• Sub-System Owners for related areas in AHQM and support / remediate any compliance risks.

• Support with Seed Management activities as a backup by ensuring seeds are produced and documented in compliant manner.

• Support with Complaints Investigation as a backup.

• Support with MEDS as a backup and being a point of contact for any escalation / troubleshooting.

• Support with Packaging record creation and verification as a backup.

This position will work closely with their respective Associate Specialists, alongside other members of Quality Assurance to provide support in multiple ways including assisting in inspections, investigations and various compliance assigned actions.

This team member may be called upon to provide documentation guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.

This team member will occasionally be expected to visit the shop floor to ensure inspection readiness activities. This role will be 90% based office setting. However, there will be occasions to backup a team member by supporting with visiting shop floor to attend Tier meetings and inspection walk arounds.

The ideal candidate seeks for opportunities to develop competency in multiple functions and systems and assist in various projects and responsibilities within the QA and manufacturing team. Serving as a backup for key functions of release, such as batch record review, will be expectation of development.

This role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty. Attributes of critical thinking, problem solving, and disciplined judgement will allow them to excel on a specialized and dynamic Quality Assurance team.

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

Additional duties will include the following:

• Proficiency in SAP, Reliance, Aera, MEDS and other related systems.

• Working knowledge in Microsoft Excel and Word would be beneficial.

• Key participant in Quality Compliance Inspections from regulatory agencies and off-site entities

• Assisting in the training for new hires and cross training the QA group

Minimum Education/Experience Requirement:

• H.S Diploma with minimum of 3 years of relevant work history required

• Bachelor's degree in microbiology, chemistry, or similar scientific discipline preferred.

Required Experience and Skills:

• One (1)+ years of experience in a regulated industry

Preferred Education Experience and Skills:

• Familiarity and/or experience with vaccine manufacturing and/or testing

• Familiarity and/or experience with USDA and or FDA regulations and inspections

• Experience in GMP and Quality Management Systems

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/31/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R340968