Job Title: Quality Technician
Job Description

The Quality Technician performs essential duties to ensure the Stability Program operates effectively and complies with US and International pharmaceutical manufacturing regulations and guidance documents. Responsibilities include the packaging, storage, and delivery of stability material in a timely manner, updating department Work Instructions or site Quality System Procedures, and developing solutions to routine technical problems to improve department efficiencies.

ResponsibilitiesManage and maintain stability samples under ICH, FDA, DEA, and cGMP regulations.Pull and deliver stability samples at testing intervals.Package stability samples per study requirements.Maintain controlled substance inventory in compliance with applicable DEA regulations.Work with the LIMS team to ensure the stability module of the LIMS system is maintained and functional.Ensure stability studies are entered into LIMS accurately and timely.Responsible for packaging, labeling, and storage of stability samples.Share responsibility for Stability Packaging functions and sample pulls as needed.Essential Skills6 months-1 year of industry experience within GMP.Lab experience with laboratory notebook experience and aseptic experience.BS degree in Biology or Chemistry preferred, but not required.Experience with quality control, Microsoft Office, and data entry.Additional Skills & QualificationsSome technical, community college, or college credits with 1-year related experience in lab, GMP.Preferred: BS Degree in Science with laboratory experience and interest in working in Stability.Knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.Excellent communication skills.Ability to work in and promote a team environment.Understanding and application of principles, concepts, practices, and standards within discipline.Knowledge of stability chambers and laboratory equipment.Ability to read and interpret graphs.Ability to lead and influence people.Understanding of basic statistical principles.Knowledge of ELN, LIMS, Excel, and MiniTab.Work Environment

The position involves 50% laboratory exposure to plant products, solvents, and reagents, some of which are hazardous or potent compounds, and 50% office environment which includes sitting for long periods of time and computer use. The role does not require a respirator but will involve working in safety hoods with packaging stability products. The work schedule is Monday-Friday.

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.