The posting
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:
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 INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):
1. Perform operational production room approvals after product and lot changes
2. Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct
3. 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.
4. 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
5. Review sampling pages to ensure samples have been taken, labelled, and documented appropriately
6. Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely.
7. Check to ensure portable equipment has been cleaned and documented correctly on quality form.
8. Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment.
9. Ensure recovery stations are segregated from product flow.
10. Confirm bulk material and components for job are correct and kept covered.
11. Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible.
12. Review temperature and humidity data to ensure within acceptable job parameters.
13. Identify proactively gaps in batch records and TER's to mitigate deviations and documentation errors. Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed
14. Support Root Cause Analysis as needed.
15. Performs/supports end of shift BR review and supports/completes FORM-0001908 (QA 903
16. Report quality event notifications for issues encountered on the production floor to OPS Mgmt.
17. Support operations by creating JDE labels for production and act as on floor SME for JDE transactions.
18. This position may require overtime and/ or weekend work.
19. Must have knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
20. Must be dependable in work attendance.
21. May perform duties of a production Supervisor and or relieve supervisors of ancillary tasks.
22. Perform other duties as assigned by Manager/Supervisor.
EDUCATION OR EQUIVALENT:
1. High School Diploma required
2. 2 - 4 years relevant experience in production, equipment and or process
3. Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred
LANGUAGE SKILLS:
1. Must possess good analytical skills and excellent verbal and written communication skills.
2. Must demonstrate effective listening, coaching and interpersonal communications skills.
KNOWLEDGE/SKILLS REQUIREMENTS:
1. Must be dependable and show initiative to improve safety, quality, through put and cost performance.
2. Must be willing to work overtime and flexible in regard to working on all 3 shifts
3. Able to balance multiple issues simultaneously in a fast-paced environment.
4. Needs good problem-solving skills, should be detail oriented and well organized.
5. Must have excellent attention to detail and possess detailed knowledge of cGMP documentation and the completion thereof
6. 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:
1. 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.
2. 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:
1. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
2. The noise level in the work environment is usually moderate.
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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.
