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- Responsible for reviewing and approving documents such as deviations, Annual product reports, product complaints, validations, non-routine batch status change requests, CAPA's, calibration non conformances, etc. (40%)
- Provides initial risk assessment of Quality events. (10%)
- Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality. (25%)
- Leads quality driven initiatives in the continuous support of Quality Improvement. (25%)
- Bachelor's degree in a scientific discipline or closely aligned field. Combination of education and experience may be substituted for degree requirement.
- Five or more (5+) years experience working in an FDA regulated industry in a quality discipline.
- Demonstrated thorough/SME knowledge in the interpretation and application of cGMP and FDA requirements.
- Advanced functional knowledge of SAP systems.
- Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines.
- Demonstrated experience with risk management.
- Manufacturing engineering experience
Senior Engineer, Quality Assurance - Minneapolis, United States - Padagis LLC
Description
Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to company policy, cGMP and all other applicable FDA guidelines. Provides leadership within the department and is sought out as a SME for quality knowledge. Develops and evaluates quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements.
Job duties:
At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.
What's Next:
At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)