Senior Specialist, Quality Assurance at Merck & Co, Inc in West Point, PA
Job Description New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law. 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Senior Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, ensures that all necessary laboratory documentation (CRs / ACRs, IOQs, PQs, etc) is reviewed, approved, valid and compliant with all site procedures, our Manufacturing Division Policies and Guidelines and Regulatory requirements. This person is accountable for working closely with the various groups within Laboratory Operations in a team environment to enable the timely testing and subsequent release of product to the marketplace. The Quality Assurance Senior Specialist is accountable for providing Quality direction and oversight to WP Laboratory Operations in the management of those areas assigned, such as Internal Auditing, Training, Change Control, Inspection Management, Documentation, Deviation Management and Risk Management in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of WP Site and our Manufacturing Division priorities. He or she will assist in driving quality improvement activities and will work to ensure alignment across Laboratory Operations. The Quality Assurance Senior Specialist will also train to provide support to Quality Assurance system functions and support Regulatory Agency inspections. Responsibilities Accountable for Quality oversight for the Laboratory shop floor Actively participates in the Tier process and use this forum to escalate concerns and best practices Conducts Quality review and approval of investigative events in Laboratory Operations Determines the effects on test result validity, for laboratory investigative events, to ensure final reportable values are representative of the product's quality Provide input on recommended CAPAs Initiates and completes review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports Initiates and completes review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility Completes training to become a qualified auditor and performs monthly internal audits of laboratory areas Writes, reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. Provides coaching and guidance to new personnel and to Quality Specialists who are training new personnel Provides support to Regulatory Agency inspections Education Bachelor degree in science, engineering, or related areas of study Required Bachelor degree, minimum three years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting Master degree, minimum two years in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting Progressive and demonstrated Quality decision making ability Principled interpersonal skills including flexibility, partnership and inclusion skills and ability to work in a team environment Demonstrated self-starter with capability to develop innovative solutions to challenges Proven analytical aptitude, critical thinking skills and ability to apply key concepts Speaks with courage and candor Strong written and verbal communication skills Preferred In-depth working knowledge and application of GMPs/GLPs Proven ability to manage multiple projects simultaneously Experience in pharmaceutical laboratory operations or related environment 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. 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:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
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:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Shift:
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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