Specialist, Quality

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. is seeking a Stability Specialist to support site stability programs and execute stability strategies for pre-commercial and commercial studies. The role involves study management, sample handling, protocol creation, and GMP documentation across domestic and international sites.

The candidate will communicate effectively with internal/external customers, participate in cross-functional teams, and represent stability on site initiatives and continuous improvement projects.

Qualifications

• Bachelor's degree in chemistry, biological science, pharmacy, or related field.
• Experience with vaccines, biologics, and/or devices preferred.
• Knowledge of analytical methods, manufacturing processes, and GMP compliance.

Responsibilities

• Manages stability studies for vaccines and pharmaceutical products, including sample handling and receipt, labeling, chain of custody, protocol creation, study builds and closeouts.
• Coordinates sample shipment/receipt with partner sites and labs.
• Reviews annual stability reviews for licensed products for accuracy.
• Addresses inquiries related to products or projects.
• Maintains GMP documentation per company policies and procedures.
• Supports deviation management and corrective actions for stability operations/testing.
• Responds to early warning limit excursions.
• Authors or revises local SOPs.
• Utilizes LIS, MS Word, Excel, and statistical software.

Skills

cGMP Compliance

Laboratory Information Systems (LIS)

Data Analysis

Documentation Management

Education

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

Tools

Laboratory Information Management System (LIMS)

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.

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 Experience

• 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}

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. We provide accommodations during the application or hiring process.

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
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.

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

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

NA

Job Posting End Date

• 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: R417666