Quality Coordinator

PCI Pharma Services is seeking a Quality Coordinator to assist with coordinating quality activities and ensure compliance with cGMP's and customer requirements.

Requirements

• Prepares and distributes required documentation for requested production work orders.
• Performs documentation and records review of completed orders to ensure compliance with cGMP's and customer requirements.
• Creates and updates batch records, forms and material specifications as well as organizes 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.
• Helps identify, communicate, track and resolve document related issues with other departments and customers.
• Functions as one of the customer points for comments or questions pertaining to batch documentation.
• Assists with providing quality related metrics.
• Performs finished product batch release of approved production lots.
• Meets with management to address issues or concerns with the batch documentation.
• Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications.
• Organizes internal and customer approval of batch records and specifications.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor.

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 401(k)