Quality Analyst / USA

The client has a Quality Analyst role.


Purpose:
During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the ABL plant including the coordination of Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, is responsible for the approval of manufacturing directions to the production floor, resolution of deviations, performance of product impact analysis and corrective and preventive action for events, participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of compliance with cGMP and policies for the manufacturing plant.

The Associate SVP Quality Analyst may support the ABL Quality Engineering group by auditing commissioning and validation documentation, authoring and execution of qualification/validation protocols, review and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, and other quality assurance tasks assigned by the SVP QA Superintendent or SVP QA Operations Manager and/or the Plant QA Manager.
* Responsible for coordinating the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and Tub Hold Management process.
* Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.
* Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.
* Support SVP Media Fill Program and QA Oversight execution activities.
* Performs product impact analyses for plant events and places product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
* Revise and/or approves standard operating procedures; ensures procedures comply with policies and cGMP guidelines.
* Approves calibration requests and ensure that these requests have appropriate product/process limits assigned
o Support SVP drug product batch record documentation review.
#qualityassurance #manufacturing