Senior Specialist, Quality Operations

Job Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

• We are seeking a Growth and Improvement minded Senior Quality Specialist that can help drive our Strategic Operating Priorities.
• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We provide an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Dedication to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

Strategic Summary
The Senior Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model, with guidance from the IPT Quality Lead, ensures product/process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system. The Senior Quality Specialist also completes approval of documents associated with deviation management, change control, validation, and external customer complaints, and provides Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls.
The Senior Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. Job functions are achieved primarily on the production shop floor and in a team environment.
Key Responsibilities

• Conducts batch release of supported products, this includes release to markets outside of the USA.
• Partners with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates.
• Assists in sending samples/lab reagents to release authorities.
• Completes required SAP transactions to release product in SAP.
• Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material.
• Completes, reviews, and sends release protocols to regulatory agencies.
• Completes approvals of Deviation Management, Change Control, Validation and External Customer Complaint documentation.
• Supports Regulatory inspections. Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors.
• Provides coaching and mentoring of manufacturing supervisors and operators.
• Conducts and completes Quality review/approval of new and updated SOPs and Controlled Job Aids.
• Assists with training of incoming personnel and ensures compliance with departmental procedures.
• Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
• Partners with IPT members in the identification and implementation of continuous improvement initiatives and action plans.

Education Minimum Requirement and Experience

• Bachelor's Degree of Science (BS) in Science, Engineering, or another technical field and four (4) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain within the pharmaceutical industry.
• Master's Degree of Science (MS) in Science, Engineering, or another technical field and two (2) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain within the pharmaceutical industry.

Required Experience and Skills

• Strong comprehension of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
• Applies knowledge of internal/external business challenges to improve products, processes, or services.

Preferred Experience and Skills

• Experience of interacting with site, divisional, or regulatory audits.
• Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion. MPS experience - LSS Green Belt certification or equivalent experience.
• Experience managing multiple projects simultaneously.
• Solves complex problems; takes a new perspective using existing solutions.
• Demonstrated self-starter with capability to develop innovative solutions to challenges.

NOTICEFORINTERNALAPPLICANTS
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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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".
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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:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/28/2024
*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:05/28/2024
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:R285519