Associate Quality Account Manager I

PCI Associate Quality Account Manager I

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.

Associate Quality Account Manager I is responsible for assisting with coordinating quality activities for 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 :

• Creates, updates and peer reviews Master Packaging Instructions, forms, and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Packaging Instructions and specifications.
• Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMPs and customer requirements.
• Assist with creating and / or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts.
• Assist as company liaison with customers concerning quality control documentation.
• Help identify, communicate, track, and resolve document related issues with other departments and customers.
• Attend or facilitate conference calls and customer meetings to provide or obtain quality related information and customer specific metrics.
• Assist with populating quality related metrics and key performance indicators for team's performance.
• Assist with initiating and investigating quality deviations with the responsible functional area.
• Initiating and completing supplier non-conformance reports and effectively implementing material control.
• Assist with training, developing, and mentoring new Quality Coordinators.
• This position may require overtime and / or weekend work.
• 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.

Qualifications : Required :

Preferred :

Equal Opportunity Employer / Vet / Disabled