Senior Specialist, Quality Assurance
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. 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 Senior Quality Assurance 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 management 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 Opportunitie and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us The Senior Quality Assurance Specialist is responsible for the Quality Assurance aspects of Change Control, including providing guidance on change level and type, facilitating change control meetings and providing guidance on change control documentation structure and task assignments. In addition, responsible for carrying out divisional requirements as necessary. Work is primarily achieved by individual or through project Teams. Understands and applies regulatory/compliance requirements relative to their role. Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. Explains difficult issues and works to build alignment around a complex situation. Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities. Key Responsibilities Guides Change Analytical Tiers Developed conceptual and practical expertise in own discipline Applies knowledge of internal/external processes to drive improvements Solves complex problems; takes a new perspective using existing solutions Works independently, receives minimal guidance Resource for colleagues with less experience within own discipline Team or project lead and lead work of others as required Promotes teamwork and open discussion of issues, coaches and guides others Guidance on change control classification and task requirements Information for regulatory inspections as requested Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international) Reviews regulatory citations and other pertinent information Ensures adherence to divisional reporting requirements and assessments of the change control system Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities Completes special projects or assignments as directed by management including conducting education and training on GMP requirements MMD Quality Assurance Support Opportunities SOP and Batch Record Management Audits and Inspections Automation Compliance Deviation Management Annual Product Reviews, Vendor Management Inspection Management, QMS/Quality Council Management Risk Management Market Actions Education Bachelor degree in science, engineering, or related areas of study Required Work independently and as a Team member with Integrity Precision Accomplishment Principled Ambition Respect Five years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility Project Management, Change Execution Management and Team Leadership in a Quality function Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment Demonstrated self starter with capability to develop innovative solutions to challenges Deliver results across diverse areas at site Proven analytical aptitude, critical thinking skills, and ability to apply key concepts Speaks with courage and candor Strong written and verbal communication skills In-depth working knowledge and application of GMPs Proven ability to manage multiple projects simultaneously. Preferred Vaccine manufacturing environment Process Change Control experience Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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. 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., 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:
Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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., 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:
Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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