Senior Specialist, Quality Control

Job Description
Our Laboratory Technical Support ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed, in alignment with our high standards of quality and 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.
We are seeking a Senior Specialist that can drive strategic priorities through technical support in our Quality Control Laboratories. This is a second shift position, focused on supporting Laboratory Operations during core second shift hours (4PM - 12AM).
Key Responsibilities

• Providing quality and technical support to Laboratory Operations, in their execution of biological assays for Quality Control testing and direct on-the-floor support.
• Advocating for safety and environmental stewardship.
• Proactively partnering with Laboratory Quality Assurance to ensure compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures.
• Conducting investigations aimed to prevent deviation recurrence, including establishing the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, completing investigational test protocols to determine root cause, product impact, event scope, etc.
• Guiding key projects that require collaboration across functional areas to drive robust processes and continuous improvement. Continuous improvement includes proactive process/assay improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve assay robustness, reduce cost, lower cycle times, or improve schedule adherence.
• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (MPS) tools, both in problem solving and day-to-day operational activities.
• Authoring and updating technical documents necessary for investigations, assay design/definition, engineering studies, change control and validation.
• Independently manage all aspects of assigned projects and run the business activities including decision making, leading laboratory investigations, stakeholder management, issue identification and resolution, understanding of capacity and demand, participating, and driving the tier process.

Education

• Bachelor of Science (BS) Degree in life science, chemistry, biochemistry, science discipline or engineering with five (5) years of experience in a GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function. OR
• Master of Science (MS) Degree in life science, chemistry, biochemistry, science discipline or engineering with three (3) years of experience in GMP manufacturing environment, people management, pharmaceutical/biological quality, operational, technical, or regulatory function. OR
• PhD in life science, chemistry, biochemistry, science discipline or engineering with no experience.

Required Experience and Skills

• Analytical aptitude, critical thinking skills and ability to apply key concepts.
• Speaks with courage and candor.
• Strong written and verbal communication skills.
• Ability to manage multiple projects/tasks simultaneously.
• Demonstrated collaboration skills including flexibility, inclusive behaviors, and the ability to work in a team environment.
• In-depth working knowledge and application of GMPs/GLPs.

Preferred Experience and Skills:

• Project management, change execution management and team leadership experience.
• Demonstrated ability to develop and implement innovative solutions to challenges.
• Demonstrated facilitative leadership skills and able to lead teams to deliver results.
• Progressive and demonstrated decision-making responsibility.

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.
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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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/29/2024
*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:06/29/2024
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:R300523