Senior Specialist, Quality Assurance - Hybrid

MSD Malaysia; Pennsylvania; Hybrid; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking company as a Senior Specialist in Quality Assurance, where you will play a vital role in ensuring compliance within the global clinical supply chain. This hybrid position allows you to collaborate across cross-functional teams, driving continuous improvement and managing significant quality events. Your expertise in Good Manufacturing Practices and quality assurance will be pivotal in enhancing operational processes and ensuring the highest standards are met. If you are passionate about quality and innovation in the pharmaceutical industry, this is an exciting opportunity to make a meaningful impact.

Qualifications

• 5+ years in pharmaceutical industry with GMP experience.
• Familiarity with batch disposition and quality assurance.

Responsibilities

• Evaluate clinical supply materials for compliance with policies.
• Coordinate quality improvements and manage investigations.

Skills

Good Manufacturing Practices (GMP)

Quality Assurance

Lean Six Sigma

Data Analysis

Communication Skills

Clinical Testing

Adaptability

Problem-Solving

Education

Bachelor's degree in a scientific or engineering field

Tools

Microsoft Excel

Microsoft Outlook

SAP

Trackwise

Job description

Senior Specialist, Quality Assurance - Hybrid page is loaded

Senior Specialist, Quality Assurance - Hybrid

Apply remote type Hybrid locations USA - Pennsylvania - West Point time type Full time posted on Posted 2 Days Ago time left to apply End Date: May 19, 2025 (7 days left to apply) job requisition id R348708

Job Description

This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.

Responsibilities may include, but are not limited to:

• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced inconformance to all applicable policies/procedures of our Company and compliance with all governing regulations.

• Coordinate and/or support the preparation of procedures, processes and quality improvements.

• Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.

• Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities.

Education:

• Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field.

Required Experience and Skills:

• Minimum of 5 yearsexperiencein the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.

• Familiarity with batch disposition (release) activities.

• Background in quality control, quality assurance, auditing or regulatory affairs.

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.

• Demonstrated teamwork skills.

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

Preferred Skills:

• Ability to independently manage multiple priorities and projects.

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

• Demonstrated analytical and problem-solving skills.

• Knowledge of Lean Six Sigma and Project Management.

• Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.

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”.

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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Required Skills:

Adaptability, Adaptability, Audits Compliance, Business, Clinical Protocol, Clinical Testing, Communication, Continual Improvement Process, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Deviation Management, Employee Training Programs, GMP Auditing, GMP Compliance, Interpersonal Relationships, Investigation Management, Lean Management, Lean Six Sigma (LSS), Management Process, Manufacturing Processes, Manufacturing Quality Control, Medical Risk Management, Medical Supply Management, Microsoft Applications {+ 18 more}

Preferred Skills:

Job Posting End Date:

05/19/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.