Quality Coordinator

PCI RFD Anderson Brecon dba PCI of IL; Illinois; On-site; USD 25,000 - 28,000; Full time

Benefits offered by this job

Paid time off

Health insurance (including dental and

Vision

Flexible spending account

401(k)

Job summary

PCI Pharma Services is hiring a Quality Coordinator in Rockford, IL for 1st shift. The role assists with coordinating quality activities for a Customer Focused Team, ensuring goals are met within time and budget while driving long-term quality customer management.

The position requires attention to detail, basic math, and strong computer skills, with 2 years in Operations/Quality preferred. The job offers competitive benefits and a chance to contribute to life-changing therapies.

Qualifications

• TABE testing requirements met at approved grade level for position.
• Basic Mathematical Skills.
• Intermediate Computer Skills: ability to perform more complex computer tasks.
• Full Professional Proficiency: speak, read, and write fluently and accurately at professional level.
• Very High Reasoning: define problems, collect data, establish facts, and draw valid conclusions.
• Preferred: follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Hold oneself in a professional manner.

Responsibilities

• Prepares and distributes required documentation for production work orders.
• Reviews and updates batch records, forms and material specifications; organizes internal and customer approvals.
• Performs and submits batch records, accountability reports and necessary documentation to customers for product release.
• Identify, communicate, track and resolve document-related issues with other departments and customers.
• Assist with providing quality-related metrics.
• Performs finished product batch release of approved production lots.

Skills

Attention to detail

Math skills

Computer skills

Fluent communication

Education

High School Diploma or GED

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 Coordinator Location: Assembly Drive, Rockford, IL 61109 Shift: 1st Shift

Summary of Objective: Assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Prepares and distributes required documentation for requested production work orders. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer requirements. Creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications. Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. 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 documentation. Assist with providing quality related metrics. Performs finished product batch release of approved production lots. Meet with management to address issues or concerns with the batch documentation. Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications. Organize internal and customer approval of batch records and specifications. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required: TABE testing requirements met at approved grade level for position. 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. Preferred Ability to follow instructions and respond to management direction. Ability to identify and resolve problems in a timely manner. Ability to hold oneself in a professional manner.

• - Ability to demonstrate attention to detail.
• - High School Diploma or GED
• - 2 years of experience in Operations/Quality and/or providing support in an office or manufacturing environment.

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).

#LI-KH1 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.