Job Description

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team) operating model. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product/process quality, represents Quality on the shop floor, ensures adherence to Good Manufacturing and Documentation Practices, and completes quality checks and SAP transactions required to release product. The Quality Specialist performs 100% process document/logbook audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT). Provides support directly to the production floor, to include oversight for adherence to cGMPs, RFT completion of production GMP documentation, and support of effective investigation of deviations.

Additionally, the Quality Specialist spends significant time on the shop floor, collaborating with Operations and Technology to enable RFT production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements. The Quality Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the IPT. The Quality Specialist performs job functions primarily on the production shop floor in a team environment.

Primary Responsibilities

• Performs review of initial review and subsequent updates to the Master Batch Records, as well as executed Batch Record Review

• Critical site reviews for per process environmental monitoring

• Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Work Instructions, Standard Business Practices, etc.

• Partners with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates

• Actively participates in the Tier process and uses this forum to escalate concerns and best practices

• Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans

• GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements.

• Provides training to incoming personnel and ensures compliance with departmental procedures

Education Minimum Requirement

• Education Minimum Requirement bachelor’s degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.

Required Experience and Skills

• Required Experience and Skills Minimum two years of relevant post-degree work in a laboratory, manufacturing, or quality position.

• Evidence of leadership skills coupled, with good verbal and written communication skills.

• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Preferred Experience and Skills

• Familiarity with GMP documentation review is a key skill necessary for success in this position

• Experience with electronic batch records (MES/ PAS-X)

• Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas

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.

VETJOBS

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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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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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:06/29/2024

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:R300077