Description

Assist with CMO batch compliance with FDA and ICH regulations and internal procedures

Handle deviations, investigation reviews and closure, and data entry

Support SOP and policy will be part of continuous improvement initiatives

Review and approve documents, including CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations, and OOS in support of product release

Data entry of lot release cycle times for metrics generation

Support a state of continuous inspection readiness.

Skills

Quality assurance, CMO, batch record review, deviations, investigation, OOS investigation, Batch record, inventory cycle count, biologics, Gmp

Additional Skills & Qualifications

BS/MS in Biology discipline and 4+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP, and JP regulations. Experience in setting up GMP operations

Microsoft Outlook, PowerPoint, Word, Excel, and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $72.00 - $82.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Dec 30, 2024.

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.