Administrative Assistant; Quality Control

CONTRACT PHARMACAL CORP•Town of Smithtown, NY

4d•Onsite

About The Position

The Administrative Assistant is responsible for assisting the QC Manager in one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) with any tasks including, but not limited to, maintenance of laboratory documentation, initiation of laboratory change controls, and direct communication and coordination between all internal departments.

Requirements

Associate’s degree preferred; equivalent years’ work experience is acceptable.
Proficiency in Microsoft Word, Excel, graphs/charts and databases.
Ability to multitask and meet tight deadlines.
Excellent organizational and follow-up skills with attention to detail.
Ability to communicate effectively.

Responsibilities

Preparation and review of the certificate of analysis (CofA) for all materials tested. Includes review of testing results reported and manufacturing batch records, as required.
Communicate and provide information to other departments, as requested.
Coordinate with the Regulatory Affairs group to maintain and update specifications as required based on regulation requirements and changes.
Manage and support the laboratory by initiating change controls, drafting revisions to QC documentation (specifications, test methods, SOPs, etc.), and completing action items within the electronic quality management system.
Maintain current and retired QC documents.
Maintain spreadsheets for tracking departmental metrics, laboratory performance, and material release.
Monitor and maintain proper inventory levels of all laboratory supplies and reagents by working with the laboratory and purchasing groups.
Interact with all outside contract laboratories used for testing of samples.
Assist with and coordinate distribution of documents, procedures, instructions, and training.
May be required to assist in performing basic related tests, as needed.
Other responsibilities as assigned by Management.