Quality Coordinator

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and
objectives of the team are accomplished within prescribed time frames and in budget.  Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

•    Prepares and distributes required documentation for requested production work orders.
•    Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer requirements.
• Creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications.
• Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
• Help identify, communicate, track and resolve document related issues with other departments and customers.
• Function as one of the customer points for comments or questions pertaining to batch documentation.
• Assist with providing quality related metrics.
• Performs finished product batch release of approved production lots.
• Meet with management to address issues or concerns with the batch documentation.
• Reviews and interprets customer standards, procedures an