QC Analytical Associate 3rd shift (10:30pm -7am)

SHARP STERILE MANUFACTURING LLC•Lee, MA

2d•Onsite

About The Position

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. Testing includes incoming materials, in-process samples, finished good and stability samples. It also includes performing experiments for method transfers, qualifications and validation. The QCA Analyst is responsible for creating and revising documents related to testing such as SOPs, test methods, protocols and reports. The position involves hands on activities such as laboratory testing, sampling of incoming materials, shipment of samples, inspection of samples and visual inspection of finished goods.

Requirements

Zero to two (0-2) years of directly related experience.
Up to one (1) year of experience in a cGMP environment under minimal supervision.
Bachelor’s Degree
Skilled in the use of Microsoft office applications such as Word, Excel, PowerPoint and Adobe Acrobat
Ability to stand and sit for prolonged periods of time
Able to lift up to 30lbs
Compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

Responsibilities

Perform laboratory testing of incoming materials, in-process, finished product and stability samples
Create documentation necessary to conduct method transfers, qualifications, and validation and perform corresponding experiments
Author and revised quality control procedures and specifications
Perform laboratory maintenance activities such as temperature checks, ordering laboratory supplies, cleaning, appropriate disposal of laboratory waste
Maintain SDS collection
Sample and dispense chemicals and manufacturing materials
Prepare shipments of samples to contract testing laboratories, including interfacing with outside laboratories
Visual inspection of finished goods
Ability to work unscheduled and overtime hours as needed
Other duties as assigned