Job Description

The GQSS Stability Coordinator has a central role in managing all Stability programs managed through GQSS. The GQSS Stability Coordinator is responsible for the end-to-end Stability process within GQSS, starting from preparing the annual master plan for the involved products, coordinating the sampling and shipping with the sites in a timely manner, ensuring protocols are correct with the Contract Testing Labs, and overseeing the entry of the results into our Company systems. The GQSS Stability Coordinator also plays a key role in the assessment of the data, and the creation of the needed trend reports to scientifically show stability performance of the products. The GQSS Stability Coordinator acts as an SME and partner to various roles within and outside of GQSS involved in the Stability program flow, such as Contract Testing Labs oversight personnel, TCS Stability Analysts (GLIMS data entry), site planners, and Global Stability.

This position reports to the Global Quality Shared Services Director or Associate Director Contract Testing Labs for general advice and instruction but can function independently.

Primary Activities

Creation of annual Site Master List for all studies managed through GQSS, based on global stability protocols

SDS Requirement creation and maintenance based on master plan

Coordination of end-to-end stability process: coordinate study start dates with sites and lab within timeline requirements; communicate with manufacturing / packaging / testing sites

Review draft revisions of General Stability Protocols

Complete Impact Assessments and/or own tasks for stability related change controls

Review and approve Batch Specific Protocols

Approve timepoints and studies in GLIMS (or SPR) as needed

Act as SME for GLIMS template updates

Create Annual Summaries and trending as required (e.g., APR, Regulatory reporting); collect data, perform statistical trends, evaluate data and document in annual Stability Summary reports (by product, by strength, by manufacturing site); act as Second Person Reviewer

Act as SME for Stability within GQSS (e.g., perform statistical trend analysis for previous interval disagreements and risk assessments; review Topic 5.3 GDL revisions; revise SOPs as required; serve on audit and inspection teams as required; support stability related lab investigations and shipping excursions)

Act as SME and oversight of data entry into GLIMS

Participate in site and off-site project meetings

Minimum Education Experience:

Bachelor’s degree in a science field with a five (5) years of stability study management testing in pharmaceutical industry experience.Required Experience and Skills: * *

Ability to effectively manage multiple and changing priorities/projects and ensure timely completion. Able to work independently with little supervision.

Understanding of pharmaceutical Stability programs and methodologies.

Communicates fluently in English, both verbally and in writing.

Preferred Experience and Skills :

Able to compile complex investigations, procedures, justifications, protocols, etc.

Identifies improvement opportunities and acts as a facilitator of change to implement improvements. Learns a variety of tools to drive continuous improvement (ex. Lean six sigma, human error prevention, etc.).

Experience with pharm, biologic and/or vaccine stability coordination, either from Site or Stability Hub perspective.

Experience in Analytical testing methods of Compendial, Microbiological, Pharmaceutical, Biological, and Vaccines.

Experience with change control.

Experience with COMET SAP for deviations and CAPA management.

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.

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 (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$101,100.00 - $159,100.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

08/30/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 08/30/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R309288