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The Quality Coordinator 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.
Job Responsibility:
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 and specifications for dissemination relative to batch records, forms and material specifications. Organize internal and customer approval of batch records and specifications
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
Requirements:
TABE testing requirements met at approved grade level for position
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions
Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables
High School Diploma or GED
2 years of experience in Operations/Quality and/or providing support in an office or manufacturing environment
Nice to have:
Ability to follow instructions and respond to management direction
Ability to identify and resolve problems in a timely manner
Ability to hold oneself in a professional manner
Ability to demonstrate attention to detail
What we offer:
paid time off
health insurance coverage (including dental and vision)