Senior Stability Specialist, Quality (Hybrid)

We are seeking a Growth and Improvement minded Senior Stability Quality Analyst that can help drive our Strategic Operating Priorities.

• 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
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Summary, Focus and Purpose

The Senior Stability Quality Analyst will support human health stability programs from any modality and be responsible for developing, implementing, and managing stability strategies and protocols, and authoring stability sections for Chemistry, Manufacturing and Control filings. This role may coordinate with global labs (including external parties) to ensure implementation and execution of stability studies, evaluate stability data (including statistical evaluation and preparation of data in regulatory filings), and participate in investigating complex atypical and out of specification stability results.

You will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on divisional initiatives.

Key Functions

• Provides timely support for temperature excursion requests
• Provides support for stability programs executed in partnership with external entities (manufacturing or testing)
• Represent stability teams at working group level meetings
• Effectively utilizes applicable computer applications, including Microsoft Word, Excel, and statistical software applications, and is sufficiently knowledgeable of Global Laboratory Information Management System
• Provides 100% second person review support for team members stability documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document
• Supports stability-related questions from regulatory submissions (RTQ)
• Authors and implements stability strategies, develops, and sustains General Stability Protocols in accordance with QMS Topic 5.3 Expiration, Retest Dating and Stability and regulatory filings
• May assist SME in the investigation of out of specification stability results, and may participate on cross-functional investigation teams to determine root cause and corrective actions
• Authors or revises Topic 5.3 documents and supporting documents related to the global stability quality system
• Collaborates with SME to develop, establish and maintain early warning limits in appropriate systems
• Evaluates in conjunction with SME significant or complex program changes for stability impact and authors stability strategies to support the changes

Education Minimum Requirement with Experience

• Master of Science Degree (MS) in Chemistry, Biological Science, Pharmacy, or related Science or Engineering field with a minimum of three (3) years’ experience in laboratory, technical services, manufacturing, regulatory, and/or quality position.
• Bachelor of Science Degree (BS) in Chemistry, Biological Science, Pharmacy, or related Science or Engineering field with a minimum of five (5) years’ experience in laboratory, technical services, manufacturing, regulatory, and/or quality position.

Required Experience and Skills

• Principled verbal and written communications

Preferred Experience and Skills

• Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance
• Experience with either vaccines, biologics, pharmaceuticals, or medical devices

This position follows a hybrid model.

U.S. Hybrid Work Model

Effective September 5, 2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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.

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.

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:

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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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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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:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R252397