Change Control Analyst - Insight Global : Job Details

The Change Control Analyst, CAR-T is responsible for change control support for the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

As the Change Control Analyst, you will:

• Support process changes arising from updates to materials, excipients or finished goods requirements • Support efforts to establish and streamline the site change control process

• Act as change control champion for operations by owning the change control from Initiation through completion

• Participate in global forums/team meetings for Change control

• Run reports and conduct data analysis to support establishment and monitoring of change control for operations.

• Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES updates.

• Lead implementation of corrections / CPAs by working with SMEs, Correction/ CPA owners, and tech writers to maintain timelines.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

• Other duties will be assigned, as necessary.

Qualifications

• A minimum of a bachelor's degree is required.

• A minimum of two (2) years of related experience in a regulated and/or research environment is required.

• Experience in the Pharmaceuticals or related industry is required.

• Strong working knowledge of current Good Manufacturing Practices (cGMP's), initiating and executing change controls is required.

• Strong project management skills desired.

• Demonstrated technical leadership within pharmaceutical or similar environment is preferred

• Experience with the start-up of new biopharmaceutical manufacturing facilities is preferred.

• Experience with Trackwise or equivalent systems is preferred

• Proficiency in English (verbal and written), strong communication skills and the ability to influence at all levels are required.

• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.

• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.

• This position will be based in Raritan, NJ but individuals will only need to come onsite 1-2 days per week.