Senior Specialist Quality Control

Job Description

Job Description:

As a Senior Specialist Quality Control, you will be working with the laboratory management to ensure all necessary training is completed efficiently and compliantly. This position will take ownership over the Quality Control training program and ensure that the laboratory analysts are appropriately skilled and qualified to perform their daily testing. This position will partner with the site stability coordinators and Laboratory teams to assist in scheduling, executing, and reviewing testing to ensure 100% on time delivery in the laboratory. The Senior Specialist will be responsible for coordinating, authoring, and approving Quality Notifications, and managing projects in alignment with the departmental and organizational strategy to achieve key deliverables. Additionally, this position will require leadership capacity as all junior analysts and incoming analysts will utilize the Senior specialist as a resource to ensure right first-time testing is achieved. Our Quality Control Stability group ensures that all marketed products are 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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsibilities include but are not limited to:

Analytical Training Program

• Managing QC Training Program including upskilling current analysts and onboarding new analysts.

• Serve as a subject matter expert for testing related inquiries.

Analytical Testing

• Coordinating, authoring, and approving Quality Notifications

• Participate and lead deviation discussions to provide feedback for Root Cause Analysis and determine appropriate CAPA’s.

• Scheduling of Analytical testing to ensure 100% on time delivery.

• Perform Routine analytical Testing and Data review.

Other activities include but are not limited to:

• Serve as QC representative for Method Transfers, support pre-PAI activities.

• Lead Method Transfers for new products coming into NASU as well as managing any transfers out of NASU.

• Participate in quality risk assessments as a Laboratory SME.

• Author, Review and approve e-val documents for Method Transfers.

• Task owner in IPI for change controls

• Provide guidance to team members.

• Provide quality control review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson laboratories.

• Involvement in continuous improvement initiatives for the laboratory.

Education Requirements

• Bachelor's degree required with an emphasis in an appropriate Scientific or Engineering field.

Required Experience and Skills

• Requires expertise in a Quality discipline and applies knowledge of internal/external business challenges to improve processes.

• At least 5 years of relevant experience involved with analytical testing and investigations.

• Works independently with minimal guidance.

• Promotes teamwork and open discussion of issues while coaching and guiding others.

• Good organizational and time management skills. Has the ability to effectively manage multiple and changing priorities/projects and ensure timely completion.

• Ability to interpret our Company Quality Policies and Guidelines for daily application. Understands and applies regulatory/compliance requirements. Experience with regulatory inspections and knowledge of regulatory agency requirements.

• Possesses advanced technical writing capabilities.

• Must possess a minimum of five (5) years of experience in a GMP pharmaceutical manufacturing facility with direct involvement in Quality functions.

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.

Residents of Colorado

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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US and Puerto Rico Residents Only:

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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:

Click here to request this role’s pay range.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R230851