Job Details
Merck & Co, Inc
Senior Laboratory Specialist, Quality Assurance
Job Description
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.
Summary, Focus and Purpose
The Senior Laboratory 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, Manufacturing Division (MD) Policies and Guidelines and Regulatory requirements. You will work 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 Senior Laboratory Specialist is responsible 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 MD priorities and will assist in driving quality improvement activities and will work to ensure alignment across Laboratory Operations.
You will also train to provide support to Quality Assurance system functions and support Regulatory Agency inspections.
Key Functions
Responsible 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
Completes review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports
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 or Master degree required | Degree in life science, scientific discipline or engineering preferred
Required
Candidates with a Bachelor degree, 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
Candidates with a Master degree, 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
Preferred
Progressive and demonstrated Quality decision making responsibility
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
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 / 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., 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.
For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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.
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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.
Residents of Colorado:
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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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R213841