QA Associate I
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POST DATE 9/1/2016
END DATE 11/16/2016
Pacira Pharmaceuticals Inc
San Diego, CA
This person is to assist and support the organization with GMP compliance; monitoring of conformance to established quality assurance processes and GMP standards in release of raw materials. Perform initial evaluation of required documentation. Assist in the identification of risk and deficiencies while working with supply operations to appropriately remedy them. This person will represent QA during the receipt and release of raw materials.
RESPONSIBILITIES (Including but not limited to):
* Receipt, quarantine and release of incoming raw materials
* Initiates documentation per SOP for receipt of cGMP materials and performs receiving inspection for some components and moves materials to quarantine status.
* Coordinates material movement, sampling and labeling of raw materials and components with Supply Operations.
* Interacts with Supply Operations personnel to resolve receipt and/or invoice discrepancies;
* Initiates and performs investigation in Quality Events in Quality System when appropriate.
* To perform the physical tasks involved in receiving, shipping and storing of raw materials, finished products, in process used materials and other supplies.
* Coordinates material and product transfer requirements directly with Manufacturing personnel.
* Performs various inventory transactions on the ERP system. Responsible for supporting complete and accurate inventory transaction documentation and files.
* Maintains required segregation, security, labeling and storage conditions for all inventory materials.
* Performs routine cycle counts, evaluates variance reports, investigates discrepancies and recommends corrective actions.
* Approves materials for release to supply operations by reviewing appropriate documentation.
* Maintains clean, organized and safe warehouse.
* Disposes of expired and nonconforming material to EHS.
* Prepares temperature sensitive filled product for shipment to commercial partners as well as contract manufacturers per SOP s.
* Assist with regulatory inspections and partner audits
* Minimum 1 year of relevant Pharmaceutical Industry Quality Assurance experience preferred.
* BS/BA degree in scientific discipline from an accredited college or university or equivalent preferred or equivalent work experience.
* Strong knowledge of GMP s and their application
* Good written, oral, and interpersonal English communication skills
* Must be competent literate and proficient with ERP inventory transactions
* Ability to handle multiple responsibilities- self motivated.
* Ability to provide clear information effectively to peers in day to day work relationships
* Willing to work with chemicals and hazardous goods.
* Knowledge of handling temperature sensitive products including exposure to environment in cold storage areas
* Familiar with clean room gowning requirements and will work in a classified environment
* Ability to lift 60 lbs. and ability to manage multiple responsibilities- self motivated
* Ability to operate material handling equipment.
* Other duties as assigned