Quality Control Coordinator

PCI Pharma Services•Rockford, IL

5d•Onsite

About The Position

The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.

Requirements

High School Diploma or GED
1-3 years related experience and/or training.
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 Standard of Report Writing

Nice To Haves

Ability to follow instructions and respond to management direction.
Ability to work independently and/or part of a team.
Ability to display excellent time management skills.
Ability to demonstrate attention to detail.
A college degree with a concentration in a scientific discipline is preferred.
The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control).
Ability to create, use and interpret scientific tables, charts, and graphs.
Any Lean Six Sigma or process improvement training is a plus.

Responsibilities

Prepares and distributes required documentation for requested production work orders.
Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements.
Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.
Prepares customer required samples for shipment according to approved shipping instructions.
Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
Organize internal and customer approval of batch records and specs.
Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements.
Perform Line Clearance inspections of equipment and production suites.
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 records.
Initiating supplier non-conformance reports and effectuates material control.
Reviews and integrates planned deviation requests into batch records when needed.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
Attendance to work is an essential function of this job.
May perform label creation duties including generating computerized labels.
May perform duties of Quality Auditor as assigned by Supervisor/Manager.
Other duties as assigned by Supervisor/Manager.