Specialist, Quality Assurance

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The main functions of the Specialist, Quality Assurance is to assist in the review of records, investigations, support of operational excellence initiatives as well as working to implement quality system initiatives and continuous improvements.

Core responsibilities:

• Supports the deviation management program including the coordination of managing Quality Notifications (QNs) in SAP to assess product impact and effective corrective actions and review of investigations.
• Review of various records impacting batch release.
• Serve as a technical subject matter expert (SME) in selected quality systems
• Provides support to Production and QC activities by ensuring released media and raw materials are available, including weekends as required
• Executes Walkthrough audits of the GMP areas of the site on a routine basis .
• Work closely with quality and other departments to ensure appropriate root cause and CAPAs are determined .
• Author/revise SOPs, methods, protocols, and trend reports .
• Provide support to all Quality related audits from external and regulatory agencies .
• Participate in Quality Risk Assessments and serve as QA SME
• Review and approve validation reports
• Identify Continuous Process Improvements to maximize efficiencies and streamline processes within the Quality

Required qualifications:

• Education Minimum Requirement: Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field.
• Required experience and skills: Minimum 2 years experience in the pharmaceutical operations, technical services and/or quality operations.
• Understanding and application of cGLPs and cGMPs.

Preferred qualifications:

• Preferred Experience and Skills: Strong verbal and written communication skills ; Prior experience in quality remediation activities, SAP proficiency
• Experience with batch release, and quality systems management;

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

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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.

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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".

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Job Posting End Date:

*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:08/22/2024

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:R306604