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Merck

Durham, NC

Senior Specialist, Audits & Compliance Quality Assurance

Location65 TW Alexander Dr, Durham, North Carolina 27713
Employment TypeFull Time
Date Posted2022-04-07
Direct Apply
Yes
Valid Through2023-03-09

Job Description:

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 customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.

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 dedicated 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 Audits & Compliance Quality Assurance Senior 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 are committed to providing 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 Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

The Audits & Compliance Quality Assurance Senior Specialist reports to the Site Quality Lead Auditor and is accountable for maintaining regulatory compliance for the cGMP Auditing and Inspection systems at our Durham Vaccine manufacturing facility. You will be part of a site-wide team conducting internal Quality audits and directly supporting external inspections, customer audits, and Divisional audits.

The role requires routine interaction with all functions directly and indirectly related to site operations and will interact with employees within their department, at all levels across the Durham site, and at our other Company sites. The Senior Specialist will also interact with representatives from regulatory agencies, customers, Divisional Auditors, and global functions.

Key Responsibilities

General Profile

  • Works in an empowered, self-directed culture with a great deal of independent decision making to plan, coordinate, and execute multiple projects in a time constrained environment

  • Maintains continuous dialogue with site Quality Management System topic owners to facilitate compliance and rapid dissemination of key issues to our Company’s management team

  • Applies risk principles to cGMP compliance concerns to proactively mitigate impact to associated materials, products and processes

Business and Functional Expertise

  • Comprehends the contributions of the audit function to regulatory and procedural compliance and ultimately to patient safety

  • Understands the fundamental business drivers for the company and how they relate to the core business function of this role

  • Influences the continuous improvement of existing and new products at the Durham site through support of effective auditing and inspection systems that will guide to the expansion of the Durham product portfolio

  • Conduct internal and walkthrough audits in accordance with our Company auditor qualification program

  • Qualify for and maintain access in aseptic processing areas

  • Schedule and complete assigned audits in accordance with the site audit program and aligned with Global Quality oversight

  • Ensure that audit tasks are completed within assigned deadlines

  • Peer-review Audit Reports and provide timely feedback

  • Compile monthly audit metrics and disseminate information to impacted groups

  • Ensure responses to audits and inspections effectively address identified gaps in compliance

  • Verify effectiveness of CAPAs initiated to address findings identified during Internal Audits, Divisional Audits, customer audits, and regulatory inspections

  • Continuously add to cutting-edge knowledge and auditing techniques for GMP topics and site processes

  • Coordinate and facilitate site third party audits and regulatory inspections

  • Provide compliance input to site development and commercial production teams

  • Assist in preparation of the site’s annual audit schedule

  • Assist with site Permanent Inspection Readiness and Pre-Approval Inspection Readiness efforts by conducting practice inspections, evaluating site presentations, ensuring necessary documentation is prepared in advance of inspections, and training participants in audit processes

  • Direct the process for writing effective, timely CAPAs in response to internal audits, regulatory inspections, customer audits, and Divisional audits

  • Train subject matter experts, CAPA owners, management, and others involved in audits and inspections on inspection processes, software for audit report and CAPA tracking, and other topics that facilitate effective audit execution and CAPA implementation

  • Assist with management and maintenance of cGMP Certifications and regulatory submissions

  • Assist with maintenance of the Site Master File

  • Participate in opportunities to conduct or host audits at other Company sites, suppliers, etc.

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Education

  • Bachelor degree in Science, Engineering, Quality, or related areas of study.

Required

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

  • Five years of working directly in Quality, Regulatory, Technical, or Manufacturing Operations

  • Demonstrated comprehension of FDA and international cGMP regulations and guidance and ability to apply them to observed processes, facilities, and equipment

  • Experience working with internal and/or external customers, understanding their concerns and challenges, while evaluating compliance with regulatory requirements, guidance, and company procedures

  • Strong critical thinking and problem-solving skills

  • Principled global communication skills (both written and verbal)

  • Ability to multitask and independently manage multiple projects and deadlines

  • Strong customer service focus

Preferred

  • Experience working directly in a Quality Assurance role in the Pharmaceutical or Medical Device industry

  • Three years related experience in conducting cGMP or Quality Audits (including planning and conducting audits, writing audit findings, reviewing CAPA plans, and verifying CAPA implementation) and/or Inspection Management in a regulated environment Working in aseptic manufacturing and/or testing processes

  • Familiarity with international Data Integrity guidance principles and ability to apply them to observed processes, facilities, and equipment

  • Knowledge of the manufacturing processes and quality systems at the Durham facility

  • Familiarity with TrackWise

  • Developing and providing training on cGMP topics

  • Auditor certification by professional organization

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., Rahway, 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.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement?

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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., 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R183163

Job ID: 7541279506891680398

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