Senior Specialist Quality, Capital Projects
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 committed 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 Capital Projects Quality 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 Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us The Senior Capital Projects Quality Specialist, with guidance from the West Point Project Quality Lead will provide capital project quality support for the construction, qualification, and licensing of a new filling/lyophilization facility at the West Point site. Candidate will be responsible for various activities that ensure compliance from initial design phase of the facility through qualification and eventually routine manufacturing and release. The SCPQS ensures all necessary documentation (MBRs, SOPs, URs, IQ/OQs, PQs, etc.) is approved, valid, and complies with all Regulatory and Manufacturing Division requirements and is responsible for working closely with the various cross functional teams to enable the timely completion of the documents required to meet all project milestones. This individual will also participate in development of the manufacturing batch records, SOPs for Quality activities, and Quality Risk Management (QRM) activities. Additional Key Responsibilities Initiates and completes Quality review and/or approval of UR/URS/IQ/OQ/PQ and other design/qualification documents Provides Quality guidance on design of facility and manufacturing processes Ensures all activities related to Quality Risk Management are completed Actively participates in the development of the Electronic Master Batch Records and all related activities such as Design Review and Quality approval Reviews and completes Quality approval for project related Change Requests Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. Actively participates in the Tier process and uses this forum to escalate concerns and best practices Collaborates with team members in the identification and implementation of continuous improvement initiatives Provides guidance to Operations on quality issues based upon experienced and mature judgment and utilizes strong interpersonal skills to work with a diverse group of personnel in handling non-routine issues Completes GMP evaluations to ensure design of facility and processes will facilitate permanent inspection readiness goals Develops quality processes for material control/product release/shop floor compliance/deviation management within the facility utilizing the established policies and guidelines Education Bachelor degree in appropriate scientific/engineering field or Bachelor degree with relevant experience Required Work independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Five years relevant post-degree work in a laboratory, technology, manufacturing, or quality position Leadership skills with principled verbal and written communications Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area Preferred Familiarity with Capital Project and/or start-up documentation such as IQ/OQ/PQ and other related documentation Familiarity with electronic batch records Familiarity with Quality Risk Management Vaccine Manufacturing Regulatory Inspections Ability to work independently in a role that is unstructured and not well defined. 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:
No 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
Business Project ManagementEstimated 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:
1st - Day Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Salary Range:
$80K -- $100K
Minimum Qualification
Business Project ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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