Reference #: JR104178Life 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: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. *This position is a weekend position-Friday, Saturday, and Sunday 8am to 8pm.

　　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.1. Perform operational production room approvals after product and lot changes2. Verifies first piece inspection to ensure finished goods code, format, and expiration date are correct3. Ensure products are packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications. If not, this individual 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 requirements5. Review sampling pages to ensure samples have been taken, labelled, and documented appropriately6. 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 flow10. Confirm bulk material and components for job are correct and kept covered11. Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible12. Review temperature and humidity data to ensure within acceptable job parameters13. 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 needed14. Report quality event notifications for issues encountered on the production floor to OPS Mgmt15. Performs/supports end of shift BR review and supports/completes FORM-0001908 (QA 90316. This position may require overtime and/or weekend work.17. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.18. Attendance to work is an essential function of this position19. 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:- High School Diploma or GED and/or 1-3 months related experience and/or training.- Basic Mathematical Skills- Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.- Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.- High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.- Must demonstrate effective listening, coaching and interpersonal communication skills

　　LI-LM1

　　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.