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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Market Actions-Health Authority Reporting Quality Senior Specialist is accountable for support of Market Actions and Health Authority Reporting activities at the site. This will include but not be limited to assisting teams and above site functional areas with assessing reportability of Product Quality Complaints (PQC) and Deviations for submission to health authorities, execution of Market Actions and Annual Market Action Challenges, adherence to procedures, and reports to site management. This position will ensure the site system is compliant with 21CFR, Divisional Standards, SOPs, and aligned with related Quality Systems, and lead discussions related to the topic during internal audits and regulatory inspections. Responsibilities will also include Market Actions/Health Authority Reporting process improvements and will provide support to the manufacturing division's Product Quality Complaint and Adverse Event investigations as required, including coordinating responses to Health Authority requests, as well as support of Deviation Management and Fact Findings. Primary activities include, but are not limited to:
Assess system health and evaluate site compliance with Quality System requirements Assess system performance; Identify and implement continuous improvement Update Standard Operating Procedures (SOPs) related to these business processes as needed Lead and facilitate the site Biological Product Deviation Report (BPDR) review process Support teams for assessing reportability of Product Quailty Complaints and Deviations Perform a review of Health Authority Reporting assessments for Product Quality Complaints and Deviations Support the teams during the BPDR draft review and approval process Perform BPDR submissions to the US FDA, as needed Support the Global BPDR Steward with ad-hoc data requests and continuous improvement initiatives Support teams for non-US Health Authority Reporting communications Coordinate Fact Finding Committee Meetings Lead Market Action Execution activities and conduct an Annual Challenge of the Market Action System, as needed Provide Market Action and Biological Product Deviation Report (BPDR) summaries for Annual Product Review requests Attend and support global CoP meetings for Market Actions and Health Authority Reporting Identify need for corrective actions related to Market Actions or Health Authority Reporting Perform and provide second person review/approval for Adverse Event investigations, as needed Lead and facilitate compliance projects to support sustaining and/or enhancing compliance Lead and facilitate MPS projects to support enhanced efficiency and effectiveness Support ad-hoc BPDR data requests from the teams Author, review, and approve procedures and other control documents Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors Assist with aspects of Regulatory Inspections, commitments and declaration requests Education Bachelor degree in science, engineering, or related areas of study Required Work independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Five years of relevant work in a pharmaceutical/biotech environment Strong written and verbal communication skills. Strong organizational skills Ability to work independently and follow up on pending actions without being prompted. Strong aptitude with Microsoft Office applications, including Word, Excel and Outlook. Technical writing or investigation writing experience Preferred Experience working in SAP, Trackwise and Spotfire applications. Demonstrated ability to analyze data, identify areas of concern and drive action. Experience with Deviation Management, Market Actions, and Complaints Experience with application of Lean Six Sigma / Merck Production System (MPS) principles and tools. 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:
Travel Requirements:
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.
Assess system health and evaluate site compliance with Quality System requirements Assess system performance; Identify and implement continuous improvement Update Standard Operating Procedures (SOPs) related to these business processes as needed Lead and facilitate the site Biological Product Deviation Report (BPDR) review process Support teams for assessing reportability of Product Quailty Complaints and Deviations Perform a review of Health Authority Reporting assessments for Product Quality Complaints and Deviations Support the teams during the BPDR draft review and approval process Perform BPDR submissions to the US FDA, as needed Support the Global BPDR Steward with ad-hoc data requests and continuous improvement initiatives Support teams for non-US Health Authority Reporting communications Coordinate Fact Finding Committee Meetings Lead Market Action Execution activities and conduct an Annual Challenge of the Market Action System, as needed Provide Market Action and Biological Product Deviation Report (BPDR) summaries for Annual Product Review requests Attend and support global CoP meetings for Market Actions and Health Authority Reporting Identify need for corrective actions related to Market Actions or Health Authority Reporting Perform and provide second person review/approval for Adverse Event investigations, as needed Lead and facilitate compliance projects to support sustaining and/or enhancing compliance Lead and facilitate MPS projects to support enhanced efficiency and effectiveness Support ad-hoc BPDR data requests from the teams Author, review, and approve procedures and other control documents Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors Assist with aspects of Regulatory Inspections, commitments and declaration requests Education Bachelor degree in science, engineering, or related areas of study Required Work independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Five years of relevant work in a pharmaceutical/biotech environment Strong written and verbal communication skills. Strong organizational skills Ability to work independently and follow up on pending actions without being prompted. Strong aptitude with Microsoft Office applications, including Word, Excel and Outlook. Technical writing or investigation writing experience Preferred Experience working in SAP, Trackwise and Spotfire applications. Demonstrated ability to analyze data, identify areas of concern and drive action. Experience with Deviation Management, Market Actions, and Complaints Experience with application of Lean Six Sigma / Merck Production System (MPS) principles and tools. 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:
Travel Requirements:
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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