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

Job Description

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 our company's 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 our company's 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 our company's 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:-

• B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology); advanced degree preferred.-

Required Experience and Skills:-

• Minimum 5 years of experience in Pharmaceutical or related industry
• Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development.-
• Strong leadership skills with the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives.
• Excellent verbal and written communication including presentation skills.
• GMP or related drug regulation knowledge and expertise.
• Ability to independently manage multiple priorities and projects.

Preferred Experience and Skills:

• Experience in non-sterile and/or sterile drug product manufacture/testing.
• Experience in excipient/component release requirements/testing.
• Experience with manufacturing investigations and CAPA's.
• Familiarity with R&D or clinical supply areas and processes.
• Knowledge and competency in SAP.
• Experience with regulatory or QP inspections.
• Superior skills in collaboration, teamwork, and conflict management.
• Strong analytical problem-solving skills.

Notice:

• The position will initially be assigned to 1st shift (e.g., 7:00 AM-3:00 PM) through the end of 2025 and into 2026. The position is expected to transition to 2nd shift (e.g., 3:00 PM-11:00 PM) in 2026. Applicants should be willing and able to accept a schedule change at that time and thereafter, to work either shift. Reasonable notice of schedule changes will be provided.

-

Requirement:

• Must be able to work on first and second shift.-

Required Skills:
Accountability, 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 {+ 4 more}

Preferred Skills:

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement•

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, 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 employee's 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 .

You can apply for this role through (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, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:
Not Applicable

Shift:
1st - Day, 2nd - Evening

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
11/22/2025
*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: R374064