Description:

• Performs and/or assists with QA review of production records and Lab reports.• Investigates non-conformance and deviation reports.• Coordinates the stability studies including reviewing laboratory reports for accuracy and preparing statistical analyses of decay curves.• Review test results for and release raw materials.• Audits production and quality control programs, reports observed deficiencies, and contributes to establishing solutions to observations.• Issues batch records, checks yield and reconciliation calculations, and fiels records for easy retrieval.• Manages validation programs related to manufacturing equipment and processes and calibration of physical testing equipment.• Receives, logs, investigates, and reports on complaints and adverse events; coordinates responses with QA Manager.

Skills:

Gmp, batch record review, Document control, non conforming, fda

Top Skills Details:

Gmp,batch record review

Additional Skills & Qualifications:

bachelors degree in a life science3-5 years in quality assurance

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.