Associate Manager of Quality - ReadyCare Waukegan
About The Position
JOB SUMMARY: - 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. CORE JOB 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. - Managecomplaints 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.
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 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.
- 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.
- Managecomplaints 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.
Benefits
- Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
- Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
- For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
