QA Specialist - Raw Materials

Job Type:
Business Transformation
Job reference:
about 2 years ago
Determines disposition of raw materials and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Clients Standard Requirement Documents.

Essential Duties and Responsibilities:

* Reviews release data, prepares appropriate release documentation and executes release of vendor raw materials.

* Performs AQL visual inspections.

* Manages QA requiFrrements of SCAR process i.e. initiation, review, approval, monitoring

* Support Supplier Quality Group as needed

* Support Warehouse &Logistics Group as needed

* Initiates, edits, review and approves change control and SOPs.

* Provide training as required within the QA Raw Materials Group

* Performs compliance monitoring of area operations and notifies area and Quality Management of any observed non-compliance.

* Participates in regulatory and customer audits

* Identify gaps in systems and develop feasible plans for correction

* Training of personnel on quality system processes

* Manages direct reports where required i.e. 30:30 performance reviews, manage tasks, coaching/training

Education and Experience:

* Requires BS/BA in scientific discipline or related field plus minimum 6 years of relevant experience. May consider significant industry experience in lieu of educational requirement.

* Minimum 2 years supervisory experience preferable.
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