Quality Specialist II

Job Description

• Provide day-to-day support to the Lab and Operations team so production timelines are met

• Assist with investigations, deviations, CAPA, validation documentation, change control, and other related controlled documents

• Review Quality Systems data for trends within assigned area of support and report to functional area management, QA and provide quality improvement training for staff as needed

• Perform QA functions related to Operations including internal audits, document review and approval, and batch record disposition

• Work closely with Facility staff to support activities that ensure control of the manufacturing cleanroom and labs

• Represent the QA group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups

• Routinely identify quality issues and report to QA staff and management

• Provide support to QA Management for third-party audits

• Assist in the raw material release process by assuring suitability of production materials

• Assist QA Management with identifying areas for quality improvement. Work with QA staff and management to develop action plans and metrics needed to monitor progress toward meeting quality improvement objectives

• Exercise discretion, judgment, and personal responsibility

• Demonstrate a high level of integrity

• Maintain a positive attitude

• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products

• Attention to detail in all job functions

• Perform tasks following established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed

• Solve, correct, prevent problems, and perform tasks as assigned by leadership, as well as assign tasks to junior staff

• Work to specific measurable objectives requiring operational planning skills with little direct supervision

• Lead and support a diverse and collaborative team environment. Utilize clear and concise communication to deliver high productivity and contribution to the success of team and goals

• Document all activities performed according to SOPs

• Make decisions based on established procedures

• Infrequent travel required

• Moderate involvement in audits

• Moderate involvement in customer relations

• Moderate responsibility for inspection outcomes

QUALIFICATIONS:

• Must possess relevant four-year Science degree (Open to BS or Master’s)

• Three years of Quality Lab Experience

• Minimum 1yr of Investigations experience doing Deviations, CAPA, and Validating Documentation

• Experience in Biologics, Gene Therapy, or Pharmaceutics preffered

• Knowledge of GMP, regulatory (FDA) requirements, and understanding of aseptic processes preferred.

• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change

• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting

• Ability to work independently as well as collaboratively in a diverse and inclusive work environment

• Must possess a client-focused mindset in daily task

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.