Senior Specialist Quality

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

The Senior Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model and 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 review and 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. 

Additional Key Responsibilities

• Become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance | Job functions are completed primarily on the production shop floor and in a team environment

• Completes batch release of supported products and this includes release to Markets outside of the US

• 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 Quality review/approval of new and updated SOPs and CJAs

• 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

• Bachelor degree or higher in Science, Engineering or another technical field or equivalent experience in the pharmaceutical industry.

Required

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect

• Four years in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance or Supply Chain 

• 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

• Ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk

• Working Across Boundaries | Principled interpersonal, communication, collaboration and negotiation to work outside boundaries as a norm

• Business Outcomes/Drive Results - Ability to use deep knowledge and expertise in production operations to drive results and business outcomes

Preferred

• Creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business | Establishing a Right First Time culture by reducing waste and constantly driving continuous improvement | Author, review and/or approve compliance documents, as per procedures or need

• Interacting with site, divisional or regulatory audits

• Ability to create an engaged workforce using Inclusion as the How 

• Knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion | MPS experience - LSS Green Belt certification or equivalent

• Proven ability to manage multiple projects simultaneously

• Applies knowledge of internal/external business challenges to improve products, processes or services

• Solves complex problems; takes a new perspective using existing solutions

• Works independently, receives minimal guidance

• Demonstrated self-starter with capability to develop innovative solutions to challenges

• Quality or Operations experience in Pharmaceutical, Biologics, Vaccines or Therapeutic Protein manufacturing

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time. 

Who we are 

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for 

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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 if you need an accommodation during the application or hiring process.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No Travel Required

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R177802