Senior Specialist, Quality Assurance

Merck; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck in Rahway, NJ seeks a Senior Specialist, Quality Assurance who reviews and approves GMP documentation for clinical supply drug product, audits batch documentation, and supports regulatory inspections.

You will collaborate with the Quality Program Lead to issue reports, drive corrective actions, and ensure adherence to GMP. On-site support for production occurs at least 60% weekly.

Qualifications

• Bachelor's degree in a science or engineering field is required.
• Minimum of 5 years' experience in the pharmaceutical industry.
• Strong knowledge of GMP, GDP and EU regulatory requirements.
• Experience in QA, QC, analytics, or manufacturing environments.

Responsibilities

• Review and approve GMP documentation for internal or outsourced clinical supplies.
• Audit batch documentation, data, procedures, and systems for compliance.
• Collaborate to issue audit reports and resolve findings with management.
• Participate in regulatory inspections preparations and execution.
• Ensure release criteria are met and maintain GMP standards.
• Lead investigations using root cause analysis and CAPA.
• Provide on-site support to production facilities (60% weekly).

Skills

Continuous Improvement

Good Documentation Practices

Good Manufacturing Practices

Quality Assurance

Standard Operating Procedure

Education

B.S. in appropriate Science or Engineering discipline

Job description

Job Description

The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures, Good Manufacturing Practices and other applicable worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notify relevant management of unresolved issues/trends.

Essential Duties And Responsibilities

• Perform Good Manufacturing Practice documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.


• Accountable for all assigned projects and communication of status to the Management team.


• Identify need for and/or develop Standard Operating Procedures to ensure practices are accurately reflected. Assist in Standard Operating Procedures and quality-related system development and approval.


• Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current Good Manufacturing Practice posture within Global Development Quality.


• Adhere to Good Manufacturing Practice and Standard Operating Procedures


• Identify and implement continuous improvement initiatives and action plans.


• Assist in preparations for regulatory agency inspections.


• Ensure procedures are followed and specifications met to release or reject materials.


• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.


• Establish, educate, and enforce standard operating procedures required under Good Manufacturing Practice.


• Participate in investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.


• Maintain a state of readiness for and participate in audits and inspections.


• On-site support of production facility & staff (minimum 60% on a weekly basis)

Education Minimum Requirement

• B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology).

Required Experience, Knowledge, And Skills

• 5 years of experience in the pharmaceutical or related industry


• Understanding of current Good Manufacturing Practices and Good Documentation Practices and related drug regulation requirements, including European Union.


• Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development


• Attention to detail, flexibility, and an awareness of production and associated quality problems.


• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.


• Demonstrated ability to manage multiple projects and priorities simultaneously, and to meet deliverables and timelines.

Preferred Experience And Skills

• Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.


• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.


• Experiences in a Good Manufacturing Practice environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.


• Ability to identify, focus, and solve problems in a timely and efficient manner.


• Experience with quality audits and EU regulatory inspections.


• Experience or working knowledge of Research & Development or clinical supply areas and processes.

Required Skills

Continuous Improvement, Good Documentation Practices, Good Manufacturing Practices (GMP), Quality Assurance (QA), Standard Operating Procedure (SOP)

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.

Requirements

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

Location

The primary location for this posting is: USA - New Jersey - Rahway

Salary

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $106,200.00 - $167,200.00

Benefits

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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/20/2026

• 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

R426723