Asst Mgr QA

Medline•Mundelein, IL

About The Position

Assist the Quality Assurance Manager with personnel, quality and regulatory oversight support. Assist with managing the activities of the quality control group to ensure quality and regulatory compliance for assigned division.

Requirements

Bachelor’s degree in Biology, Chemistry, or related science and Engineering.
At least 3 years experience in pharmaceutical or medical device good manufacturing practices.
Intermediate computer skill level.
Experience applying knowledge in project management.

Nice To Haves

Experience in drug product manufacturing and drug regulations.
Experience in the indirect management of team members, including assisting in the development, training, and assignment of work/projects.

Responsibilities

Assist the QA Manager with personnel, quality and regulatory oversight support including the daily operation of the unit.
Perform quality and/or regulatory reviews of labeling and other documentation for compliance with stated requirements including applicable OTC drug monographs, procedures and quality records.
Assist the division in product evaluation from a quality assurance and regulation compliance standpoint.
Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
Review all purchased products or components and provide input to the decision of whether to accept the product and future purchases from the vendor.
Manage complaints and develop new approaches to solve problems identified during quality assurance activities.
Assist in preparing reports to communicate involvement and results of quality assurance activities.
Prepare and present technical and program information to team members and management.