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 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
- competitive total rewards package
- continuing education & training
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- Employee Assistance Program
- Employee Resource Groups
- 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
