Supervisor, Clinical IQA I

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Summary of Objective:

• Primary function is to assign and Supervise Quality Assurance subordinates all QA review activities relating to the laboratory, to ensure timely and accurate execution in accordance with established standards by performing the following duties personally or through subordinate staff.
• There are supervisory responsibilities.
• Primary function is the timely and efficient 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, Water activity and Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Review of raw data generated for stability testing, release testing, cleaning verification, method transfers, method development and validation.
• 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 including working with internal and external customers to resolve issues.  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 and validation protocols and reports. Assis/lead customer audits.
• Reviews Excel and Chromeleon templates for validation.
• Review URS/IQ/OQ/PQ documentation relating to the introduction of new equipment.  Participate in projects to improve efficiency and overall quality of work.
• Allocation of QA activities to subordinates including collaboration with other department supervisors to ensure on time completion of all data. Oversight and management of the Microbiology Laboratory employees and processes, and supervisory responsibilities.

Essential Duties and Responsibilities:

GENERAL 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
• Works in an efficient manner to generation and documentation of raw data in accordance with ALCOA principles
• Knowledge of ICH Guidelines which pertain to services trained to review
• Knowledge of USP and EP general chapters which pertain to techniques trained to review
• Training of personnel in review in area of expertise
• Attendance at huddles including leading on a rotating basis
• 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
• Maintains a high level of good housekeeping
• Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence
• Implementation and execution of continuous improvement activities
• Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

SPECIFIC RESPONSIBILITIES

• Issue notebooks, worksheets and test forms in accordance with defined procedure
• Timely and efficient review ensuring accuracy, completeness and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met including data integrity of: manual/automated  titrations, UV, FTIR, LOD, Karl Fisher, Water activity, Incoming component testing, Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Water testing, Stability data, Release data, Cleaning verification data, Method transfer, validation raw data including protocols and reports, Calibration data
• Timely and efficient review ensuring ac