Specialist Product Quality

Summary:

The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.

Responsibilities:

• Build and maintain technical GMP documents and product stability studies
• Review, verify, report, and archive GMP data for clinical and commercial products
• Apply keen attention to detail to conduct data review and reports
• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
• Adeptly manage time-sensitive activities independently
  
  

Basic Qualifications:

• Doctorate degree OR Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, OR Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate’s degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience OR High school diploma / GED and 12 years of Quality, Operations, Scientific, or Manufacturing experience
  
  

Preferred Qualifications

• Bachelor's degree or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• Experience working in a regulated environment (either direct GMP or technical support)
• Previous experience with either synthetic or biologic stability program management (e.g., designing studies, authoring stability study documents, reviewing data monthly and annually, coordinating with Supply Chain/Manufacturing groups to obtain samples, collaboration with Quality Control testing groups, etc.,).
• Strong project management skills
• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
  
  

Top 3 Must Have Skill Sets:

• Stability Study Design
• Data Analysis
• Technical Writing
• GMP or previous pharmaceutical experience
• Must have a degree; science background is preferred
  
  

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.