Easter Seals Jobs

Job Description

Position Description:

This role will support the Elkhorn, NE manufacturing site by leading a small team of personnel and will serve as the as the team leader of the Quality Assurance team responsible for the Elkhorn site’s Raw and Printed Material Release. This team member will serve as the site Subject Matter Expert (SME) in all aspects of Raw and Printed Material Management.

This team member will provide guidance to the Elkhorn site and team personnel around the quality and compliance of Raw and Printed Material Management; thus, they will need to have knowledge of local and global Animal Health standards, USDA regulations, and cGMP’s.

Typical job duties for this position include, managing a small team, dealing with day-to-day issues as they arise. Additionally, leading long term projects around Raw and Printed materials, aligned with site priorities and objectives. This role will also include approving, updating, and writing SOPs, PPMs, and Biospecifications. This team member will also serve as the primary Quality Assurance representative on Raw and Printed material Events, Change Controls, and Annual Outline Reviews.

The Quality Assurance Senior Specialist will be instrumental in the operations of the Elkhorn Manufacturing Facility. They will conduct annual inspections within the various site departments while assisting in prioritization and execution of Quality Compliance actions assigned to the site. Additionally, this role will be 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.

Additional duties will include the following:

• Perform high level functions in SAP.

• Participation in Annual Outline Review.

• Participation in Change Controls and Event Classification and Review.

• Key participant in Quality Compliance Inspections from off-site entities.

• Other tasks as assigned by QA Manager and Quality Director.

• Manage Supplier Audits and Auditing Schedules for the Elkhorn site.

Education Minimum Requirement:

• Bachelor’s Degree (degree in Chemistry, Biology, Microbiology or related sciences)

Required Experience and Skills:

• Minimum of five years of experience with Raw and Printed Material management in a regulated industry (USDA regulatory experience preferred).

• Strong written and verbal communication skills.

• Experience with investigations and risk assessments.

• High attention to detail surrounding shifting priorities within the organization.

Preferred Experience and Skills:

• Prior people management experience highly preferred

• Familiarity and/or experience with 9 CFR and VSM requirements regarding raw and printed materials.

• Basic knowledge of other USDA regulations and inspections, such as: Annual Outline Review, Regulatory Inspections, and VSM 800.91.

• Project Management experience.

• Experience in SAP, Aera and Reliance or similar systems.

#EBRG

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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, generally Tuesday, Wednesday and either Monday or 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”.

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

07/19/2024

*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.

Job Posting End Date: 07/19/2024

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: R300354