QA Specialist

QA Specialist 2 page is loaded## QA Specialist 2locations:
Rockford, IL, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR116767

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 of Objective:
** Primary function is the timely and efficient advanced review ensuring accuracy, completeness and compliance to in–house, customer and regulatory requirement, including data integrity, are met following the testing of pharmaceutical starting materials, components and finished products using techniques such as manual/automated titrations, UV, FTIR, LOD, Karl Fisher, HPLC, GC, TOC, Water activity and Pharmacopoeial testing i.e. LOD, RI, , Limit tests, Review of raw data generated for stability testing, release testing, cleaning verification and method transfers.

Training of personnel in data review in area of expertise, including mentoring and coaching. Author OOS investigations, determination of root cause and develop and implementation of corrective and preventative actions. Author investigations into deviations from defined procedures. Review of regulatory bodies for changes applicable to the laboratory and ensuring that any changes are implemented. Maintain metrics with respect to area of responsibility.

Write, review, and revise work practices, and test methods. Review and approval of stability protocols, Review and approval of method transfer protocols and reports. There are no supervisory responsibilities.
* Timely and efficient review ensuring a high level of accuracy with minimal personal error, completeness and compliance to requirements to ensure that Quality Assurance standards and regulatory requirements are met, including data integrity
* Record and maintain all related data and records in compliance with cGMP and ALCOA principles
* Knowledge of USP/EP general chapters and ICH guidelines which pertain to job function
* Train other associates in data review for which expertise/competency has been demonstrated
* On time completion of assigned training in Compliance Wire
* Participate in internal Health and Safety audits including developing actions and follow up
* Participates in internal, customer and regulatory audits
* Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence
* Participates in implementation and execution of continuous improvement activities
* Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory
* Knowledge of and adhere to all PCI, cGMP, and GCP policies, procedures, rules
* Embodies cultural values and aligns daily actions with department goals and company culture
* This position may require overtime and/or weekend work
* Performs other duties as assigned by Laboratory Management
* Performs review of microbial testing and analytical chemistry testing related to QC functional responsibilities. Supports Commerical and Clinical stability and release by performing review of analytical testing of raw materials and drug products for the following tests in accordance with GMP, GLP and company test methods:
* Issue notebooks, worksheets and test forms in accordance with defined procedure
* Plans and organizes work with periodic supervision and communicates data review progress to Laboratory Management as needed
* Ability to interpret different customer method requirements with minimal supervision
* Actively participates in and method transfer and/or method validation activities between facilities within the organization or between organizations by reviewing method transfer protocols and reports for any of the above analytical testing listed
* Technical Data Review of New/Revised Test Methods/SOP’s/Work Practices
* Authors deviation investigations, Out of Specification investigations, Out of Trend investigations, develops  Corrective Actions/Preventative Actions as needed.
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