Reference #: JR104020Life 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

　　Perform operational production room approvals after product and lot changesVerifies first piece inspection to ensure finished goods code, format, and expiration date are correctEnsure 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 requirementsReview sampling pages to ensure samples have been taken, labelled, and documented appropriatelyAudit 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.Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible.Review temperature and humidity data to ensure within acceptable job parameters.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 neededSupport Root Cause Analysis as needed.Performs/supports end of shift BR review and supports/completes FORM-0001908 (QA 903Report quality event notifications for issues encountered on the production floor to OPS Mgmt.Support operations by creating JDE labels for production and act as on floor SME for JDE transactions.This position may require overtime and/ or weekend work.Must have knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

　　EDUCATION OR EQUIVALENT:High School Diploma required2 - 4 years relevant experience in production, equipment and or processPackaging, 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 shiftsAble 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 docume tation and the completion thereofMust have excellent interpersonal skills able to lead and direct union associates and communicate effectively with all levels of management.

　　EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED

　　Join us and be part of building the bridge between life changing therapies and patients.

　　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.

　　LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.