Job Description
Urgently hiring a QA Batch Record Reviewer to support a backlog of batch records for a CDMO generic pharmaceuticals.
Essential Duties:
- This is a short-term contract (1-3 months) and will be 100% fully remote (Need to be local to NJ/NY/CT)
- Performs batch record review and release for Third party manufactured solid oral dosage products.
- Review analytical testing results for solid oral dosage products for release.
- Initiating and conducting Investigations.
- Tracks metrics for external businesses partners/CMOs on product releases and rejections.
- Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial).
Qualifications:
- Candidate must have a minimum 3 years of experience in the pharmaceutical industry for solid oral dosages. (No Biologics).
- Position requires a bachelor's degree in chemistry, General Biological or Physical Science
- Experience in supporting deviations, investigations especially, OOS investigations. Experience in conducting, writing/reviewing deviations and investigations, root cause analyses, and identifying corrective actions. Good to have previous experience with Third party / supplier Quality.
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.