Quality Control Coordinator

Essential Duties And Responsibilities

• Prepares and distributes required documentation for requested production work orders.
• Performs 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.
• Organizes internal and customer approval of batch records and specs.
• Performs line clearance inspections of equipment and production suites.
• Helps 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.
• Initiates supplier non-conformance reports and effects material control.
• Reviews and integrates planned deviation requests into batch records when needed.
• Adhere to PCI and cGMP policies, procedures, rules and regulations.
• Attend 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.

Required Qualifications

• A High School Diploma or GED.
• 1-3 years related experience and/or training.
• Basic Mathematical Skills.
• Intermediate Computer Skills.
• Full Professional Proficiency in speaking, reading, and writing.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions.
• 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.

Pay

For Illinois residents: The hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).