Specialist, Quality

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 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.

• 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

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

• 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

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. We provide accommodations 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.

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The salary range for this role is
$87,300.00 - $
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,…