Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • North Scituate

Description

Company Description

A leading Bio- Pharma industry


Job Description

Ideal candidate- • B.S. 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). Strong project management skills

Day to Day Responsibilities:

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.

As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
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.

Key Responsibilities include:
• 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


Qualifications

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


Additional Information

Top 3 Must Have Skill Sets:

Experience working in a regulated environment (either direct GMP or technical support)
Strong project management skills
Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques

  • ms project
  • quality control