Sr. Spclst, Quality
The Quality Senior Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas comply and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area.
Specific responsibilities include but are not limited to the following:
1. Becomes fully trained in Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Senior Specialists.
2. Learns cGMPs, the manufacturing process, and quality systems.
3. Responsible for reviewing and approving Quality Notifications, Change Requests, Technical Documents.
4. Works cross-functionally to resolve outstanding issues related to the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material.
5. Participates or Leads in Quality Risk Assessments as appropriate
8. Ensures compliance with departmental procedures.
9. Actively participates in both Operations and Quality tier process and uses this forum to escalate concerns and best practices.
10. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
11. Provide release or CBER submission support if needed.
13. Helps to maintain the Permeant Inspection Readiness of the facility by supporting walkthroughs, GEMBAs and Key Topic discussions
14. Provides Audit and Inspection support as needed
Education Minimum Requirement and Experience:
- Bachelor of Science (BS) degree in a science, engineering, or related area of study with five (5) years of experience in Quality Operations, Quality Control (Laboratory Operations or Environmental Monitoring), Quality Assurance, Manufacturing Operations, or related field.
Required Experience and Skills:
- Strong understanding of regulatory requirements (domestic and international)
- Evidence of leadership skills coupled with good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
Preferred Experience and Skills:
- Aseptic/Sterile processing experience preferred.
- Demonstrated leadership expertise working with cross-functional teams on complex projects.
- Deviation Management Experience.
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.
Flexible Work Arrangements:On-Site
Shift:1st - Day
Valid Driving License:No