Quality Coordinator

PCI Pharma Services•Rockford, IL

2d•Onsite

About The Position

The Quality Coordinator assists with coordinating quality activities for a designated Customer Focused Team, helping ensure team goals and objectives are completed within prescribed time frames and budget. The role supports project success and long-term quality customer management. It prepares and reviews production and batch documentation, supports product release, tracks documentation issues, and serves as a customer contact for batch-documentation questions. The position is based at Assembly Drive in Rockford, Illinois, and is listed as 1st Shift. Overtime and/or weekend work may be required.

Requirements

Meet TABE testing requirements at the approved grade level for the position.
Basic mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency in speaking, reading, and writing fluently and accurately at levels pertinent to professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.

Nice To Haves

Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to conduct oneself professionally.
Attention to detail.
High school diploma or GED.
Two years of experience in Operations/Quality and/or providing support in an office or manufacturing environment.

Responsibilities

Prepare and distribute required documentation for requested production work orders.
Review completed orders and records for compliance with cGMPs and customer requirements.
Create and update batch records, forms, and material specifications, and organize internal and customer approvals.
Prepare and submit batch records, accountability reports, and other required documentation to customers to facilitate product release.
Help identify, communicate, track, and resolve documentation-related issues with other departments and customers.
Serve as a customer point of contact for comments or questions about batch documentation.
Assist with providing quality-related metrics.
Perform finished-product batch release for approved production lots.
Meet with management to address batch-documentation issues or concerns.
Review and interpret customer standards, procedures, and specifications for dissemination related to batch records, forms, and material specifications.
Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
Perform other duties as assigned by the Manager or Supervisor.