Job Description

Position Overview – Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

The Laboratory Specialist within the Quality Operations department, with guidance from the Associate Director of Quality Operations, provides support to Laboratory Operations. The Laboratory Specialist will support sample tracking and scheduling, perform performance trends, manage inventory, facilitate collaboration meetings, engage in project work, and support other business needs at the direction of the Associate Director.

The Laboratory Specialist will work closely with the assigned laboratory in a team environment to ensure timely turnaround of laboratory testing and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management coordinate day-to-day schedule and perform historical performance trends. They may also assist Laboratory Operations in conducting investigations associated with sample scheduling or other related topics. Additionally, the Laboratory Specialist will also support project work as needed and lead collaboration meetings within the department and participate in those outside the department.

The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.

THIS IS A DEVELOPMENTAL ROLE INTO AN LABORATORY MANAGER POSITION. IF YOU ARE NOT INTERESTED IN BECOMING AN LABORATORY MANAGER, PLEASE DO NOT APPLY. You will be expected to remain in this role for a minimum of two (2) years. Promotion into an Operations Manager role is not guaranteed and is dependent on the incumbent's execution of the tasks and expectations of the role.

Primary Activities:

• Responsible for the scheduling of lab testing and performing sample tracking from receipt to approval.

• a. Maintain metrics and tracking associated with this testing and approval.

• b. Complete remediation activities for all samples, to ensure roadblocks are appropriately corrected in a timely manner.

• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Quality on resolution.

• Facilitate collaboration meetings with the Quality team to drive on-time testing and participate in meetings with external customers to provide testing updates.

• Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans.

• Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.

• Work with members from Quality and Technical Services to properly handle unplanned events impacting laboratory samples.

• Participate in design and implementation of training and development programs.

• Foster a customer service attitude across the network.

• Assist with training of incoming personnel.

• Provide support to Regulatory Agency inspections as needed.

• Develop, Update and Modify SOP’s as needed.

• Skills (include specific skill levels required to apply our Company's Leadership Principles)

Education:

• Bachelor’s degree. Degree in life science, scientific discipline or engineering preferred OR M.S. degree in life science, scientific discipline or engineering.

• In lieu of a Life Sciences or other Bachelor’s degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.

Required Experience and Skills:

• Minimum 1-2 years experience 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 Experience and Skills:

• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

• Demonstrated analytical aptitude, critical thinking skills and problem solving skills.

• Demonstrated ability to upskill / coach others.

• Strong written and verbal communication skills.

• Strong organizational skills.

• Experience in pharmaceutical laboratory operations or related environment

Shifts:

• 1st Shift: M-F - 8a-5p
• 2nd Shift: M-F - 3p-12a
• Must be willing to work weekends when needed

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.

VETJOBS

MSJR

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.

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:

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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.

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”.

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:R289601