Overview
We are seeking a Specialist, Quality Assurance to support the Quality Assurance department in the development, implementation, communication, and maintenance of quality system policies and procedures to ensure compliance with regulatory requirements related to Good Manufacturing Practices (GMP) for the manufacture, packaging, analysis, and distribution of solid oral pharmaceutical products for the U.S. (FDA), European (EMA), and Canadian (Health Canada) markets.

Responsibilities

• Develop and maintain internal quality procedures and systems to ensure compliance with GMP

• Maintain, support, and improve the following programs and processes:

• Corrective and Preventive Action (CAPA) program

• Internal audit program

• Supplier qualification program

• Document control and change control

• Client complaint management process

• Continuous quality improvement process

• GMP training program for employees

• Cleaning verification program

• Environmental monitoring program

• Support upper management in:

• Monitoring and assessing the effectiveness of quality systems

• Improving productivity and/or diversification of company services or markets to ensure GMP compliance

• Support QA during audits (clients, internal, regulatory authorities, and suppliers) of the company’s quality systems

• Approve Manufacturing, Packaging, and Labelling Master Files

• Issue manufacturing, packaging, and labelling files

• Perform risk assessments when introducing new APIs or implementing changes

• Perform production room clearance and equipment cleanliness verification

• Review reception files

• Review and write specifications for raw materials and packaging components

• Review Certificates of Analysis for raw materials, packaging components, and finished products

• Review executed production records (manufacturing, packaging, labelling)

• Review stability summary reports

• Perform any related duties

Requirements

• Bachelors in Chemistry, Pharmaceutical Sciences, or related field

• 7+ years in life sciences Quality Assurance experience

• Strong knowledge of GMP and quality systems in pharmaceutical environments

• Good leadership, organization, and problem-solving skills

Pay: From $76,000.00 per year

Work Location: In person