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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 :
*Due to business needs and necessity all schedules are subject to change*
This position directly supports the direction, organization, alignment, monitoring and cGMP compliance to ensure the successful, cost effective, timely and safe packaging of customer orders. The position audits production room documentation, checks equipment challenges, in-process inspections and ensures samples/AQL requirements are met. These associates are responsible for performing real time batch record and documentation review and or co-signs during batch processing to drive improvements into our Right First Time (RFT) metrics. They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform operational production room approvals after product and lot changes
Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
Ensure products are packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this will contact the appropriate personnel to recalibrate and/or remediate the issue.
Review batch record (MPI’s) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet AQL requirements
Review sampling pages to ensure samples have been taken, labelled, and documented appropriately
Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely.
Check to ensure portable equipment has been cleaned and documented correctly on quality form.
Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment.
Ensure recovery stations are segregated from product flow.
Confirm bulk material and components for job are correct and kept covered.
EDUCATION OR EQUIVALENT:
High School Diploma required
2 - 4 years relevant experience in production, equipment and or process
Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred
KNOWLEDGE/SKILLS REQUIREMENTS:
Must be dependable and show initiative to improve safety, quality, through put and cost performance.
Must be willing to work overtime and flexible in regard to working on all 3 shifts
Able to balance multiple issues simultaneously in a fast-paced environment.
Needs good problem-solving skills, should be detail oriented and well organized.
Must have excellent attention to detail and possess detailed knowledge of cGMP documentation and the completion thereof
Must have excellent interpersonal skills able to lead and direct union associates and communicate effectively with all levels of management.
COMPUTER SKILLS :
Must be computer literate with past experience using MS Office, Lotus Notes, spreadsheets and ERP systems.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk and stand. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision.
WORK ENVIRONMENT:
EQUAL OPPORTUNITY EMPLOYER/VET/DISABLED
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