- Manage the Quality Assurance Technicians and Inspectors, provide guidance and leadership to Quality and Operations
- OOS, NCM investigation, review, approval
- Drug and Device Complaint Investigations
- Develop and train QA Techs and Inspectors. Provide ongoing education and training as needed for production associates relative to cGMP, Deviations, NCMs, and other components of the Quality System
- Participate in Regulatory / 3rd Party / Customer audits as needed
- Create and/or update Procedures and Work Instructions as needed and review regulated procedures and processes for compliance
- Provide oversight as needed for DHR/Batch Record Review
- Provide assistance with validations as needed
- Provide direction for production stoppage due to Quality concern, restart production
- Bachelor's degree in Biology, Chemistry, Quality or other technical field .
- 3-5+ years of supervisory/management experience
- cGMP training
- 5+ years of experience in a Quality Operations or Operations experience preferred in a GMP environment
- Proficiency with Microsoft Word, Excel, PowerPoint
- Ability to create and interpret technical documents
- Experience in ANSI sampling plans or equivalent
- Process experience in a FDA manufacturing environment
- Experience and knowledge of regulatory requirements (21CFR 210, 211, 820)
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Quality Operations Manager - Morristown, United States - Rockline Industries & Iatric Manufacturing
Description
Are you ready for a new challenge? Come join our team Iatric Manufacturing Solutions, a wholly owned subsidiary of Rockline Industries, is dedicated to helping foster healthy environments through the design and manufacturing of FDA-regulated wipes for use in the consumer, health care, food service, and hospitality industries. Iatric will operate out of a new 435,000-square-foot state-of-the-art FDA-registered facility in Morristown, TN. The wholly owned subsidiary was born out of the rapidly increasing demand for Iatric's innovative wet wipes products that are designed to support healthier, sanitary environments and personal hygiene.
The Quality Operations Manager oversees the daily operation of the Quality Operations Department, providing support to Operations, dealing with supplier and customer quality issues. The Quality Operations Manager is responsible for the performance and objectives of the QA Techs and QA Monitors, managing document change, maintaining product and process specifications to meet internal and external customer expectations. This role is responsible for the hold and release of raw materials and finished goods, through the QA Techs, to meet regulatory and performance specifications. Additionally, the Quality Operations Manager participates in and ensures the QA Technicians participate in Non-Conformance investigations, ensuring thorough investigations, accurate Root Cause Analyses and appropriate CAPA and effectiveness checks.
Responsibilities include:
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)
