Quality Control Coordinator

PCI TRGR Penn Pharmaceutical Services Ltd; Rockford (IL); On-site; USD 25,003 - 28,130; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k)

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd in Rockford, IL is seeking a Quality Control Coordinator to support QA/QC activities, ensure cGMP compliance, and assist with batch records and product release.

You will prepare documentation, review orders, verify specs, prepare samples, and coordinate approvals with customers and internal teams. A high school diploma and 1-3 years related experience are required; proficiency with MS Office and basic computer skills are expected.

Qualifications

• High School Diploma or GED.
• 1–3 years related experience or training.
• Basic mathematical skills.
• Intermediate computer skills: able to perform complex tasks in various programs.
• Full Professional Proficiency: speak, read, and write fluently for professional needs.
• Very High Reasoning: define problems, collect data, and draw conclusions from complex instructions.
• High standard of report writing.
• Lean Six Sigma or process improvement training is a plus.

Responsibilities

• Prepare and distribute required documentation for production work orders.
• Review orders to ensure cGMP compliance and customer requirements.
• Interpret customer standards and specs for batch records and materials.
• Prepare samples for shipment per shipping instructions.
• Submit batch records and docs to customers for product release.
• Coordinate internal and customer approval of batch records and specs.
• Perform line clearance inspections of equipment and production suites.
• Identify and resolve document-related issues with other departments.
• Serve as customer point for batch record questions.
• May perform label creation duties and quality auditor duties as assigned.
• Shift is Monday through Friday 8:00 am to 5:00 pm.

Skills

1-3 years related experience

Basic mathematical skills

Intermediate computer skills

Professional proficiency in spoken/wr

Strong analytical ability

Excellent report writing

Education

High School Diploma or GED

Tools

MS Office

Master Control

Job description

## Quality Control CoordinatorApplylocations: Rockford, IL, USAtime type: Full timeposted on: Posted Todayjob requisition id: JR118633Life 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.**Position Title: Quality Control Coordinator****Location: Linden Road, Rockford, IL 61109****Shift: 1st Shift 7am - 3pm****SUMMARY**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.**Essential Duties and 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.* Shift is Monday through Friday 8:00 am to 5:00 pm.**Qualifications:****Required:*** 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**Preferred:*** 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.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. 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).