Quality Control Coordinator

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 25,000 - 28,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage

Flexible spending account

401(k)

Job summary

PCI Pharma Services in Rockford, IL seeks a Quality Control Coordinator to support quality activities and ensure timely goals. You will help review batch records, prepare documentation for production orders, and assist with deviations and supplier issues within a cGMP framework.

The role emphasizes attention to detail, strong time management, and collaboration across departments. Illinois residents may expect a competitive hourly wage with bonus eligibility.

Qualifications

• High School Diploma or GED with 1-3 years related experience.
• College degree in a scientific discipline preferred.
• Ability to prepare and review batch records and documentation.
• Strong written and verbal communication in a cGMP environment.
• Proficiency with MS Office and Master Control software.

Responsibilities

• Prepare and distribute documentation for production work orders.
• Review batch records for compliance with cGMP and customer specs.
• Coordinate sample shipments and documentation for product release.
• Perform line clearance inspections and record reviews.
• Assist with deviation requests and supplier non-conformance processes.

Skills

Attention to detail

Time management

Independent work

Team collaboration

Analytical thinking

Education

Bachelor's degree in a scientific discipline

Tools

Master Control

MS Office

Job description

Life 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: Assembly Drive, Rockford, IL 61109 Shift: 1st Shift

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:

• 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 ("MS Office") and technical software ("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.

Benefits:

• paid time off
• health insurance coverage (including dental and vision)
• flexible spending account
• 401(k)

Equal Opportunity Employer/Vet/Disabled Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.