QA Specialist 2

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Position Title: QA Specialist II

Location: Assembly Drive, Rockford, IL 61109

Department:  QC Laboratory

Shift: First

Reporting To: QA Supervisor

Responsible For (Staff): None

The primary function is the timely and efficient advanced review ensuring accuracy, completeness, and compliance to in–house, customer, and regulatory requirements, 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, ID, 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 development 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 ensure that any changes are implemented.  Maintain metrics concerning 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.

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.

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 efficiently met including data integrity Works to generation and documentation of raw data by 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 the review in the area of expertise.

• Attendance at staff meetings/laboratory departmental communication huddles. 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 extra hours and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

SPECIFIC 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 Issue notebooks, worksheets, and test forms by a 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 Basic review as needed for 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 and Method transfer.

• Advanced reviews for microbiological data, Stability Protocol, Method Transfer/Method Verification protocols for assigned Clients, advanced Stability data for assigned clients, and cleaning validations. 

• Drive on time completion of data correction activities in conjunction with the area Supervisor.

• On time Produ