- · 1 - 3 years of laboratory experience.
- Bilingual (English and Spanish) required.
- Knowledge of GMP regulations.
- Computer literate.
- Detailed oriented.
Previous experience working in production or QC preferred - Complies with all cGLP/GMP and safety requirements, laboratory SOP’s and Company policies.
- Maintains appropriate documentation (records and lab notebooks) as required by SOP and cGLP for the stability program.
- Creates protocols for stability.
- Generates quotes for new stability clients.
- Knowledge of physical testing according to USP.
- Knowledge of the procedure of the samples that enter the stability program, the samples that are in the stability chambers, and stability protocol schedule.
- Knowledge of the procedure of samples sent to outside laboratories.
- Responsible for developing, generating, and editing controlled documents such as certificates of analysis, reports, laboratory notebooks, physical and chemist records. (support to Q.A Finished product Release)
- Revise and deliver packing list from packing department. (support to Q.A Finished product Release)
- Responsible for the release/rejection of the finished product (order or packing list) upon review of all the quality documentation. (support to Q.A Finished product Release)
- Ensures limited or no disruptions to the operations by processing documents on time while ensuring compliance with company policies and procedures. (support to Q.A Finished product Release)
- Meticulously review batches to ensure completeness and accuracy before the batch release. (support to Q.A Finished product Release)
- Responsibilities include document review to ensure accuracy, secure storage, efficient access to technical documentation for review or updating and maintenance of documentation files/databases to ensure data accuracy. (support to Q.A Finished product Release)
- Follow the instructions and pre-established guidelines to perform the functions of the job.
- Performs other clerical functions as requested by the immediate Supervisor.
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| QUALIFICATIONS: |
- 1 - 3 years of laboratory experience.
- Bilingual (English and Spanish) required.
- Knowledge of GMP regulations.
- Computer literate.
- Detailed oriented.
- Previous experience working in production or QC preferred.
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