Actalent’s Remote QA Team Meets Pharmaceutical Distribution Goals; Reduces Demand on Client’s Employees

Client Profile

Our client is a large biotechnology company that researches, develops, and commercializes innovative therapeutics for oncology, antiviral, cardiovascular, respiratory, and liver disease.

The Challenge

Our client has been facing talent shortages and workflow disruptions due to turnover in multiple areas, including batch record review—a critical step that ensures pharmaceutical products were consistently produced and controlled according to quality standards and regulations. Due to the high volume of work and limited capacity of existing staff, the client hired Actalent to complete this specialized work.

The Actalent Approach

Actalent developed a customized, in-sourced functional service program (FSP) that would involve the recruitment and assembly of Quality Assurance (QA) professionals with batch record review expertise.

Given the ongoing shortage of talent with specialized skillsets, Actalent made a compelling case regarding the benefits of a remote workforce (increased productivity, broader pool of candidates) and provided a detailed plan for the management of the remote workforce.

With the client’s approval, Actalent assembled a Batch Record Disposition Team, comprised of twelve experienced professionals. Team Leads created, implemented, and conducted oversight of the entire batch record review process (approximately 300 batches per year), to ensure adherence to regulatory guidelines for receiving countries, verification of product materials and known restrictions, data verification—test results, calculations, specifications, appearances, expiration dates, fill-by-dates, and genealogy,

and analysis for product deviations/non-conformances. Upon final review, the Batch Record Disposition Team signed off for product release.

The Results

• Demands on full-time employees were significantly reduced: Between April 2018 and December 2022, Actalent is projected to save the client’s full-time employees an average of 20,400 hours by assuming responsibility of critical, batch record review tasks.
• Batch-release goals were consistently attained: The client established a 21-day performance metric for the completion of batch reviews and product releases. The Actalent team consistently achieved this indicator of success, releasing 95 percent of batches within 21 days.
• Client increased the Actalent team’s scope of responsibilities and promoted team members into leadership positions typically offered to full-time employees: This team quickly became an invaluable resource to the client due to their ability to hit the ground running to establish a streamlined process that met critical metrics and high-quality standards. The client was so pleased with our progress, they promoted several Actalent consultants to leadership roles generally reserved for full-time employees. These promotions earned our team members a 15 percent pay increase - validating the merit they brought to the organization.