QA Specialist - Batch Record Review

Opportunity to gain experience in the pharmaceutical / biotech industry!

• Executes batch record review

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

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

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

• Reviews routine 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

• May participate in compilation of metrics (e.g. APR, QMR, etc…)

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

• Interfaces with contract manufacturers to address documentation and compliance issues.

• Perform other work as assigned

• May participate in development of training programs regarding all aspects of producing quality products.

Additional Skills & Qualifications:

• 1-3 years of experience relevant to job description.

• GMP knowledge and understanding required; biotech / pharma background would be highly preferred

• Product knowledge - prefer oral solid dose - packaging tablets

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.