Specialist, Quality

Responsibilities

• Manages stability studies for vaccine and pharmaceutical products, including 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 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.

Qualifications

• Required: Bachelor’s degree in chemistry, biological science, pharmacy, or a related science or engineering field.
• Preferred experience:
  • Prior experience in laboratory, technical services, manufacturing, regulatory, or other quality positions.
  • Experience with vaccines, biologics, and/or devices.
  • Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) compliance.

Skills

• 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

Pay

The salary range for this role is $87,300.00 – $137,400.00, with eligibility for an annual bonus and long‑term incentive where applicable.

Benefits

• Medical, dental, vision, and other healthcare insurance benefits for employee and family.
• Retirement benefits, including a 401(k) plan.
• Paid holidays.
• Vacation time.
• Compassionate and sick days.

Employment Details

• Employee Status: Regular
• Relocation: No relocation assistance
• Visa Sponsorship: Not provided
• Travel Requirements: No travel required
• Flexible Work Arrangements: Not applicable
• Shift: 1st – Day
• Valid Driving License: Required
• Hazardous Materials: Not applicable