What are the responsibilities and job description for the Compliance Specialist II-1st Shift position at Careers Integrated Resources Inc?
1st Shift:
Position Summary
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Core Responsibilities:
This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Label and Packaging operations, finished goods and raw material disposition.
Responsibilities include:
Performing finished product disposition in accordance with Client SOP's, in-house product specifications and market regulations
Reviewing and approving validation protocols and change controls
Authoring, revising and reviewing SOP's through Veeva System
Utilizing Veeva to complete investigation of deviations, CAPAs and Change Controls
Supporting compliance walkthroughs, Participate in internal audits
Participate in QA audit readiness program as well as assist and participate in external audits and regulatory inspections
Interpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trends
Completing analysis, identifying issues and providing recommendations for compliance improvements
Completing Quality Events in Veeva
Development and training of new staff as needed
Participate in specialized projects both within Quality and cross-functionally
Perform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lots
Support additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming Materials
Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities
Maintaining material master data in ERP system
Following accurate oral & written procedures in performing QA tasks
Staying up-to-date on training of all procedures
Routinely and safely handle high value product vials in various stages of packaging completion
Adhering to Client's safety procedures and guidelines
Participate in Lean initiatives to improve Quality processes
Participate in the QA consistency meetings to support continuous improvement efforts
Support the QA on the floor initiatives which includes; attending daily capacity management and QDCI meetings and assisting customers with resolution of issues in real time
Effectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashion
Ensure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)
Comply with the requirements of Client s health and safety program.
Position Summary
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Core Responsibilities:
This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Label and Packaging operations, finished goods and raw material disposition.
Responsibilities include:
Performing finished product disposition in accordance with Client SOP's, in-house product specifications and market regulations
Reviewing and approving validation protocols and change controls
Authoring, revising and reviewing SOP's through Veeva System
Utilizing Veeva to complete investigation of deviations, CAPAs and Change Controls
Supporting compliance walkthroughs, Participate in internal audits
Participate in QA audit readiness program as well as assist and participate in external audits and regulatory inspections
Interpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trends
Completing analysis, identifying issues and providing recommendations for compliance improvements
Completing Quality Events in Veeva
Development and training of new staff as needed
Participate in specialized projects both within Quality and cross-functionally
Perform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lots
Support additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming Materials
Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities
Maintaining material master data in ERP system
Following accurate oral & written procedures in performing QA tasks
Staying up-to-date on training of all procedures
Routinely and safely handle high value product vials in various stages of packaging completion
Adhering to Client's safety procedures and guidelines
Participate in Lean initiatives to improve Quality processes
Participate in the QA consistency meetings to support continuous improvement efforts
Support the QA on the floor initiatives which includes; attending daily capacity management and QDCI meetings and assisting customers with resolution of issues in real time
Effectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashion
Ensure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)
Comply with the requirements of Client s health and safety program.
