at PCI Pharma Services in Rockford, Illinois, United States
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.
Summary of Objective:
Responsible for managing the daily operations of the IQA Receiving and the Quality Operations departments through the activities of the Quality Supervisors, Leads, Auditors, and Inspectors. Responsible for the quality issues identified during production and or Incoming Quality Assurance.
Essential Duties & Responsibilities:
+ Manage the performance and activities of Quality Operations and IQA Supervisors for Plant 1, Plant 2, Plant 3, Plant 5, Forrest Hills and Machesney Park.
+ Create, revise and or implement procedures, work instructions, forms and job aids applicable to the department.
+ Define and develop test methods to comply with industry expectations.
+ Ensure cGMP compliance and adherence to SOPs.
+ Responsible for overseeing quality improvement processes related to Quality Operations and Incoming Quality Assurance.
+ Provide 24 hour coverage for Quality related issues either by phone or email.
+ Oversee departmental training compliance.
+ Provide tours of functional areas for Customer and Regulatory Audits
+ Review documents related to Quality Operations and Incoming Quality Assurance
+ Review documents related to other departments (Validations, Quality Engineering, etc.)
+ Complete, review and approve investigations, action items in Master Control as needed.
+ Oversee Rapid Intervention process to determine root cause and appropriate CAPA’s
+ Oversee Batch Record Right First Time Program
+ Deliver presentations to All-Associates as needed Oversee incoming/audit inspections ensuring product and batch record documentations meets established standards.
+ Measure, evaluate and monitor Quality metrics/department data (i.e. Line Clearance Observations, Product Holds, Near Miss, Internal BR RFT) to identify gaps, risks, and opportunities for improvement.
+ Approve purchase requisitions for the department in the JD Edwards System.
+ Manage the department’s headcount and budget.
+ Ability to assess situations and make sound decisions for Quality non-conformances.
+ Ability to work well in a team environment (communicates well during conversations/meetings, active listener, responsible and honest)
+ Ensure the IQA and Quality Operations department is staffed appropriately to support production demands.
+ Schedule Preventative Maintenance and repairs for testing equipment.
+ Perform routine and quarterly audits of retain sample areas, warehouses, NMR and Scrap cages.
+ This position may require extra hours 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/Director.
Qualifications:
Required:
+ Bachelor’s Degree in a related field and/or 5-10 years related experience and/or training.
+ College Level 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 effectively present information to various people as the job requires.
+ Ability to display a willingness to make decisions.
+ Ability to display excellent time management skills.
+ Ability to work independently and/or as part of a team.
+ Certification in Regulatory/Compliance type expertise
\#LI-LM1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
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.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
