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Job Title: Associate II, Product Disposition
Job Location: Shreveport, Louisiana
· Makes decisions to disposition (approve or reject) batches (or lots) of active and inactive (i.e. excipients) raw materials, components, bulk drug product and finished drug product in accordance with standard operating procedure and process and after ensuring that all elements required to make a disposition decision are present as part of the batch or lot record and that they have been correctly reviewed and approved including but not limited to production and packaging records, testing records, investigations of incidents and deviations, records of receipt and other vendor records, process validation and regulatory approval.
· Completes SAP transactions and/or other records to approve or reject batches in a manner consistent with SOPs and production and planning schedules.
· With the Supervisor, Product Disposition resolves issues related to the ability to provide disposition decisions and communicates the status of batches within the organization.
· May review production or packaging records for completeness, accuracy and conformance to process to provide additional capacity in this area.
- Associate degree in a science related to the manufacture and testing of pharmaceutical products with experience in an in-process quality role is required. Lesser academic qualifications in conjunction with significant experience in a Quality role may be considered for this role.
- Demonstrated ability to rigorously adhere to defined process requirements.
- Ability to change priorities and work in a highly detailed manner in an environment with time pressure.
- Good verbal communication skills.
- Demonstrated ability to work with computerized systems. Knowledge of the use of SAP as part of a Quality system is a benefit.
- Must be able to work flexible work shift including days, nights and weekends per the needs of the business.
Dr. Reddy's Laboratories, Inc. - 14 months ago