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Job Description

**Position Description:** The Quality Assurance Specialist role is responsible for providing guidance and support to implement, execute, and oversee compliance and quality-related processes in accordance with applicable GMP requirements and our company's Animal Health Quality Systems. The position will assist engineering, material management, supplier quality management, and warehouse areas, and will provide overall support with quality audit (internal and external).

Other expectations include:

+ Knowledge and experience in assessing quality impact and GMP requirements applicable to qualification and validation of highly complex engineering and IT projects related to pharmaceutical product Manufacturing and Quality Control.

+ Work experience in supporting engineering and maintenance-related processes in a pharmaceutical industry environment, such as GMP documentation review, deviation investigation, change control management, review and approval of commissioning and qualification documents.

+ Understanding of supplier quality management systems and experience in, implementation and execution of the business processes to improve and prevent issues related to quality and compliance of purchased materials and contracted GMP services.

A successful candidate would need overall knowledge in a range of GMP regulations and guidelines, including GMP regulations such as USDA 9 CFR, FDA 21 CFR, EudraLex, ISO 9001 / ISO 15378, ICH Q7, and ICH Q9. This suggests the candidate will evaluate supplier compliance with these standards, ensuring the quality and safety of goods and services used in the pharmaceutical industry or other regulated product.

Other competencies a successful candidate should present:

+ Collaboration with stakeholders and a focus on problem solving, considering a balanced risk approach, and creating value for the business.

+ Effective oral and written communication, and ability to negotiate, lead, and influence others.

+ Time management, discipline, and organizational skills to deliver according to project timelines and aligned with company KPIs.

+ Autonomy to provide guidance and make timely decisions related to identified quality and compliance issues.

+ Teamwork, innovation, and ownership.

Duties and Responsibilities

+ Performs 3rd party (material supplier, service providers and contracted manufacturer) audits, timely write audit reports, work with suppliers to remediate audit observations, prepare and review supplier quality agreements and other documents supporting the External Network Quality Systems.

+ Ensures appropriate CAPAs are assigned and properly completed by the 3rd party, addressing observations from the audit.

+ Develops and executes supplier quality management improvement activities by assessing compliance with company requirements, developing methods and documents detailing processes for supplier oversight and quality improvement, providing training to other areas involved within the company, and ensuring conformance with requirements.

+ Coordinates the execution of containment, root cause analysis, and effectiveness reviews for identified quality issues at suppliers and materials and services provided by third parties. Receive notification and timely escalate any issues related to materials and services provided by 3rd parties based on compliance, regulatory, and business risk to the appropriate management level within the organization.

+ Builds and maintains strong relationships and communication plans with 3rd parties and internal stakeholders.

+ Interacts with internal auditors and stakeholders, and supplier counterparts to resolve moderate to complex, systemic quality issues.

+ Oversees materials management activities and supplier management programs and is a primary point of escalation for any Warehouse (receipt, storage, and destruction of purchased materials) and Procurement-related issue impacting purchased materials. Support with deviations, change controls and risk assessment documents related to materials management and warehouse operations.

+ Provides support to engineering and maintenance-related processes impacting manufacturing and quality control operations to ensure compliance with regulatory and our company's Animal Health requirements.

+ Reviews and approves engineering and maintenance-related documentation, such as SOPs, commissioning, and qualification documents for equipment, utilities, and automated/computerized systems; supports deviation investigation and definition of CAPAs and oversees the change control management process for the introduction and change of existing equipment, utilities, and systems.

+ Utilizes data to define and recommend new or improved quality processes to assure product quality and resolve processing, inspection, and release problems.

+ Serves as a backup for release of incoming raw materials and regulated packaging components.

+ Contributes to the site inspection readiness plan by conducting Quality internal audits and facility documents audits, writes up findings and ensures compliance with 9CFR and our company's Animal Health Quality Manual. Lead as front room personnel during external audits such as corporate audits as well as USDA audits.

+ Works under general administrative direction occasionally with some latitude for unreviewed actions or decisions.

+ Provides mentorship and training to other Quality representatives to be backups for the roles mentioned and support with creating and revising overall SOPs in Quality Assurance area.

Experience / Education / Skills Requirement:

+ Bachelor of Science degree in Pharmaceutical Engineering, Biotechnology, Physics, Chemistry or Biology.

+ 3+ years of relevant experience in supporting and/or executing QA roles for engineering, material management, Procurement and 3rd party audits.

+ Working Knowledge with inspections based on 9 CFR, 21 CFR, EudraLex, ISO 9001 / ISO 15378, ICH Q7, and ICH Q9 requirements will be a bonus.

+ Proficiency in SAP, Deviation/change control management system, Aera, and other related Quality systems.

+ Working knowledge in Microsoft Office (Excel, PowerPoint and Word).

+ Ability to travel within the U.S. up to 25% of the time.

+ Regular and reliable attendance is an essential function of this job.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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/)

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Aseptic Manufacturing, Auditing, Batch Record Review, Consulting, Corrective Action Management, Data Analysis, FDA Compliance, Good Manufacturing Practices (GMP), GxP Validation, Management Process, Personal Initiative, Policy Development, Quality Assurance (QA), Quality Control (QC), Quality Improvement Programs, Quality Standards, Teamwork, Test and Evaluation (T&E)

Preferred Skills:

Job Posting End Date:

06/4/2025

*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:** R350466