Overview
Quality Assurance Floor Representative – Night Shift Jobs in Indianapolis, IN at Lilly
Cosway Company, headquartered in Carson, California, is a full-service, fully integrated contract manufacturing provider of personal care products across the cosmetic, OTC and medical device product segments. We are searching for a Manager, Quality System Compliance, to help lead our company in this critical area.
To learn more about us, please visit: www.cosway.com
Job Summary
The Manager, Quality System Compliance will provide leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. Ensures processes and tools are established to ensure ongoing compliance with applicable requirements. Supports external audits by the FDA, the customer, other regulatory bodies and third parties, and coordinates responses to applicable audit findings. Provides support to internal functions in the understanding and adherence to cGMP Guidelines. Manages a centralized strategy for Documentation Control. Promotes teamwork, accountability and a culture of Continuous Improvement.
Duties & Responsibilities
Is directly responsible for ensuring that Cosway’s quality systems are in compliance with the applicable regulations and national & international quality standards;
Provides support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes;
Assists the Director of Quality with all internal and external audits. Assists coordinating responses to applicable audit findings;
Prepares performance reports and metrics for the Quality Management System and assist other departments in establishing reports to support evaluation and improvements of ongoing business activities;
Manages all submitted customer complaints and CAPA’s to resolution.
Leads and manages a closed-loop Continuous Improvement process.
Coordinates efforts associated with the preparation of regulatory documents and/or submissions.
Manages the process and maintenance of a centralized SOP process.
Stays up to speed and communicates with regulatory agencies on changes to regulations that affect Cosway operations.
Maintains all Quality licenses and registrations.
Other projects as assigned by management.
Minimum Qualifications
7 to 10 years of experience in an FDA regulated industry;
2 years of experience in a management role with demonstrated leadership skills;
Direct experience with FDA 21 CFR 211 and cGMP guidelines;
Direct experience in quality system audits;
Strong communication skills;
Excellent documentation skills;
Flexibility and adaptability;
Preferred Qualifications
Experience in OTC contract manufacturing environment;
Prior experience with Document Control systems, procedures, best practices;
Project management experience is preferred;
Education
B.S. in Engineering, Science or an equivalent combination of education and experience is preferred.
Job Type: Temporary
Pay: $92,000.00 – $98,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Ability to Relocate:
Carson, CA 90810: Relocate before starting work (Required)
Work Location: In person
Title: Quality Assurance Floor Representative – Night Shift
Company: Lilly
Location: Indianapolis, IN
