Sr. Stability Program Specialist

PCI Pharma Services•Rockford, IL

1d•$22 - $25•Onsite

About The Position

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. Position Title: Sr. Stability Program Specialist Location: Assembly Drive, Rockford, IL Shift: 1st Shift Summary of Objective: The Stability Program Manager position is an integral member of the Quality Control Laboratory team supporting as the subject matter expert for the Laboratory stability chambers and maintain management of the PCI Stability Program which includes managing ICH Stability studies under cGMP conditions. The includes preparing samples, timely launch of stability studies, maintain pull dates and testing, reconciliation and removal of samples from the chambers, management of the stability schedule, logging stability samples into LIMS, and setting up new product/test specifications when it is required. The Laboratory Specialist will also ensure on-time completion and scheduling of all chamber preventative maintenance and calibration activities. Upon completion of each stability study in the program, the Stability Program Manager shall clear the chambers of associated product, contact the Client for disposal requirements and manage the entire Laboratory pharmaceutical product/hazardous waste program. In addition, this position is responsible for managing contract laboratories including sample shipping, analytical testing, invoicing, and results distribution to the appropriate Laboratory Department. This position also serves as one of the Laboratory Safety Officers for the site.

Requirements

Bachelor's Degree in a related field and/or 5-10 years 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.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
High Standard of Report Writing
Ability to follow instructions and respond to management direction.
Ability to exhibit sound and accurate judgement
Ability to demonstrate excellent time management skills
Ability to take ownership of issues and works towards resolution

Nice To Haves

High Standard of Report Writing

Responsibilities

Receipt and logging of samples into LIMS including setting up new product/test and specifications
Works in an efficient manner to a high level of accuracy with minimal personal error
Generation and documentation of raw data in accordance with cGMP and ALCOA principles
Knowledge of ICH Stability Guidelines
Training of analysts in stability program management in the absence of the Stability Program Manager
On time completion of assigned training in ComplianceWire
Participate in internal Health and Safety audits including developing actions and follow up
Participates in internal, customer and regulatory audits
Retains laboratory raw data/products upon completion of testing and retaining of raw data upon issuance of analytical report/CoA
Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence
Ensure that all waste materials/solvents are disposed of in a safe and timely manner.
Leads/participates in implementation and execution of continuous improvement activities
Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory
Efficient organization skills, including the ability to manage multiple processes and priorities effectively
Excellent communication skills (written and oral), including the ability to navigate potentially challenging situations
Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively across Laboratory Departments in order to successfully execute the task assigned
Ability to work independently and within team
Strong computer skills (Microsoft Excel, Powerpoint, Word, and LIMS)
This position may require extra hours and/or weekend work.
This position will require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies in the stability chambers
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Performs other duties as assigned by Manager/Supervisor.
Primary management of all stability studies in the Laboratory including real-time studies, intermediate studies and accelerated studies
Initiation of Stability Studies and set down of samples on stability including review and generation of required documentation in accordance with defined procedures
Authoring new stability protocols. Review and approval of stability protocols.
Management and documentation according to cGMP and ALCOA standards in all ongoing stability protocols
On time removal of stability samples from chambers per master schedule. Accurate completion of stability study reconciliation
Serve in a customer facing role as subject matter expert on new and current projects involving stability.
Participation in weekly project management calls with PCI customers on the status of stability testing and upcoming pulls
Distribution of completed stability testing COA’s to the associated customers. Archiving of data upon completion of the testing period
Assist in the retrieval and sending of raw stability data upon customer request
Ordering of all inventory and equipment associated with the PCI stability program
On time expiration review of chemical reagents utilized in the stability testing per defined frequency.
Management of all PCI Reference Standards including expiration review and customer contact for retest data/new certificates of analysis upon reference standard expiry period.
Maintain Laboratory pharmaceutical product waste/hazardous waste program including management of weekly waste pickups from outside waste vendor and ensurance that all hazardous waste is safely maintained.
Customer contact and proper disposal and management of samples from the stability chambers after the study has completed.
Generation of hazardous waste documentation and ensuring all hazardous waste documentation is kept in an orderly fashion.
Provision of hazardous waste documentation when required by regulatory authorities
Coordination of all laboratory DEA products which includes: creating and issuing new log forms, maintaining the sign in log, requesting clearance for new analysts, disposing of old DEA product per federal regulations, control of incoming DEA samples, training of analysts on proper handling of DEA product, and providing the annual inventory list to the DEA
Coordination of preventative maintenance, calibration and repairs of each of the PCI Stability chambers including scheduling maintenance prior to the required timeframe and coordinating other internal required departments (Security, Facilities, and Calibrations).
Review of preventative maintenance and calibration documents pertaining to the stability chambers
Response to stability chamber alarms and working with the Facilities Department to assist in troubleshooting of equipment. Performance of alarm testing at random intervals.
Management of the Stability On-Call program for the Laboratory which includes scheduling of analysts for the on-call program and ensuring adequate coverage is maintained 365 days per year
Participation in stability chamber investigations, including generating all requested data from products stored in the chambers during the affected time frame and assessing potential product impact
Management of PCI sub-contract Laboratories including sample shipping, analytical testing coordination, invoicing, and results distribution to the appropriate internal Department. Serves as primary PCI Laboratory contact for external Laboratories.
Management of external stability sub-contractors to prepare, launch, initiate and maintain stability studies over the course of the study
Ensures samples which require shipment to approved subcontractors is performed in accordance with procedure which includes obtaining the correct shipping materials (Templates, Insulated Boxes, Overnight Shipment, Custom Critical Shipments)
Orders reagents, consumable and reference materials required for analysis to ensure Laboratory is adequately stocked for all testing being performed
Processes all reagents, consumable and reference materials upon receipt so that they are available for use
Receives and processes samples from internal and external customers for analysis so that they are available for testing
Management of the entire laboratory waste program, which includes proper disposal and management of samples from the stability chambers after the study has completed. Generating proper documentation associated with the waste disposal
Acts as the designated Laboratory Safety Officer (LSO) with the proper knowledge, tools and resources (internal and external) to ensure that the Rockford Laboratory is in compliance with the Global Laboratory Safety policy. This involves participating in the development, and maintenance of a site laboratory safety plan that is in compliance with the Global policy and local regulatory requirements. The LSO ensures all Laboratory Staff maintain compliance to the requirements outlined by Global EH&S and regulatory, performs monthly inspections of Laboratory operations to ensure compliance to the program, assists and/or leads in the investigation into Laboratory Safety incidents, including near misses, and regularly leads discussions/training with the Laboratory staff on EH&S topics pertinent to the Laboratory

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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