Specialist, Quality

MSD Malaysia; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs, execute stability strategies, and manage samples, protocols, and GMP documentation across global sites.

The role involves cross-functional collaboration with internal and external partners to ensure compliance and timely study delivery. The position requires a Bachelor's degree in a related science and experience with GMP, vaccines, and analytical methods.

Qualifications

• Bachelor's degree in chemistry, Biological Science, Pharmacy, or related field.
• Experience with GMP, vaccines, biologics, and/or devices; working knowledge of analytical methods and manufacturing processes.
• Strong understanding of regulatory requirements and quality systems.

Responsibilities

• Manage stability studies for vaccines and pharmaceutical products, including sample handling, labeling, chain of custody, protocol creation, study builds, and closeouts.
• Coordinate sample shipment and receipt with partner sites and labs.
• Review annual stability reviews for licensed products for accuracy.
• Provide timely responses to product or project inquiries.
• Maintain GMP documentation per company policies and procedures.
• Support deviation management and corrective actions related to stability operations.
• Respond to early warning limit excursions.
• Draft or revise local Standard Operating Procedures.
• Utilize LIS, MS Word, Excel, and statistical software for stability documentation and reporting.

Skills

Aseptic Manufacturing

Biologics

cGMP Compliance

GMP Documentation

FDA Regulations

Data Analysis

Deviation Management

Laboratory Information Systems (LIS)

Quality Control Systems

Education

Bachelor's degree in Chemistry or related Science

Tools

Laboratory Information Management System (LIMS)

Microsoft Word

Microsoft Excel

Statistical software

Job description

Job Description The Stability Specialist will support site stability programs and be responsible for executing stability strategies and protocols for both pre-commercial and commercial stability studies. This role will facilitate stability study management, including sample receipt, sample handling, protocol creation, stability study monitoring, and all associated GMP documentation. The Stability Specialist will support cross functional teams, including our Company sites and third parties as well as domestic and international sites. The employee will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site initiatives and continuous improvement projects.

Key Functions

• Manages stability studies for vaccine and pharmaceutical products, including but not limited to sample handling and receipt, sample labeling, managing sample chain of custody, protocol creation, study builds, and study closeouts
• Collaborates with partner sites and labs to coordinate sample shipment and receipt
• Reviews annual stability reviews for licensed products for accuracy
• Addresses and provides timely responses to product or project inquiries
• Maintains GMP documentation per our Company policies and procedures
• Supports deviation management for events related to stability operations or testing of stability samples.
• Supports implementation of corrective actions
• Responds to early warning limit excursions
• Authors or revises local Standard Operating Procedures
• Effectively utilizes applicable computer applications, including Laboratory Information Management System, Microsoft Word, Excel, and statistical software applications

Required

Bachelor's degree in chemistry, Biological Science, Pharmacy, or related Science or Engineering field

Preferred

Prior experience in laboratory, technical services, manufacturing, regulatory and/or other Quality position Experience with vaccines, biologics, and/or devices Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance

Required Skills

• Adaptability
• Adaptability
• Aseptic Manufacturing
• Biologics
• Biology
• cGMP Compliance
• Chemistry
• Data Analysis
• Decision Making
• Deviation Management
• Documentation Review
• Document Management
• FDA Regulations
• GMP Documentation
• Good Manufacturing Practices (GMP)
• Interpersonal Relationships
• Laboratory Information Systems (LIS)
• Laboratory Management
• Laboratory Operations
• Laboratory Quality Control
• Pharmaceutical Sciences
• Quality Auditing
• Quality Control Systems
• Quality Inspections
• Quality Operations {+ 9 more}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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

The salary range for this role is $87,300.00 - $137,400.00. 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 https://jobs.merck.com/us/en/compensation-and-benefits.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): NA

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.

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.