Senior Specialist, Quality Assurance - Non-Sterile Product Quality Operations

Senior Specialist, Global Development Quality Operations

The Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support of the companys clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and / or regulatory inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and / or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and the companys requirements. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues / trends.

Specific and / or additional duties may include, but are not restricted to :

• Advise supported areas on requirements for all assigned project responsibilities as related to quality and the companys standards and communicate project status to management.
• Act as Development Quality representative for in-house or outsourced manufacturing for clinical supplies. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and / or out-of-specification approval, etc.
• Identify need for and / or develop SOPs to ensure practices are accurately reflected. Assist support areas in SOP and quality-related system development and approval.
• Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and / or deliverables.
• Independently prioritize work in support of multiple projects including clinical supply disposition commitments and maintenance of a cGMP posture within Global Development Quality.
• Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection.

Education Minimum Requirement :

Required Experience and Skills :

Preferred Experience and Skills :

Notice :

Requirement :

Required Skills :

Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development, Communication, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control, Microbiology, Molecular Microbiology, Physiology, Process Improvements, Quality Assurance (QA), Quality Assurance Systems

Preferred Skills :

Current Employees apply

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Current Contingent Workers apply

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US and Puerto Rico Residents Only :

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit :

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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, Monday - 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".

The salary range for this role is $104,200.00 - $163,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only : We will consider for employment all qualified applicants