Quality Assurance Specialist

Description:

Role and Responsibilities:

• Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial Drug Product in compliance with FDA and international health agency requirements.

• Review executed production batch records, environmental monitoring data (as required), and associated documentation, including any deviation and investigation reports related to lot release of Clinical/Commercial Drug Product in support of product disposition.

• Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations

• Interface directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.

• Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.

• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.

• Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

• Write, revise, and review standard operating procedures.

• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.

• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).

• Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes.

• Normally receives very little instruction on routine work, general instructions on new assignments.

• Assist in departmental planning activities to ensure that deliverables are provided according to project timelines

Essential Duties and Job Functions:

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.

• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs).

• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.

• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.

• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

• Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes.

• Normally receives very little instruction on routine work, general instructions on new assignments.

Skills:

quality assurance, batch record review

Additional Skills & Qualifications:

Knowledge, Experience and Skills:

• Good working knowledge of Quality Systems, FDA/EMEA Standards, current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)

• Excellent knowledge of six sigma, LEAN and root cause analysis tools for identifying and correcting deviations

• Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors

• Ability to effectively participate in cross-functional teams

• Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives

• An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures

• Excellent attitude with strong verbal, technical writing, and interpersonal communication skills

• Self-starter, able to work independently

• Experienced business traveler a plus (approximately 10%)

Basic Qualifications:

• 4+ years of relevant experience in a GMP environment related field and a BS OR 2+ years of relevant experience and a MS.

• Prior experience in pharmaceutical industry is beneficial.

• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates working knowledge of quality assurance systems, methods and procedures.

• Demonstrates knowledge of FDA / EMEA standards and quality systems.

• Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.

• Demonstrates audit and investigation skills, and report writing skills.

• Demonstrates good verbal, written, and interpersonal communication skills.

• Demonstrates proficiency in Microsoft Office applications.

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.