Labeling Compliance Analyst (Project Management)
About the Family: We have been family-owned since 1908 and treat customers, patients, and employees like family. It drives our unique connection with health care professionals, and it's what makes their success our success. For us it's personal listening, advising, supporting, and celebrating them as we pursue a shared vision to help the world look better, feel better and live better.
We are a leading, global aesthetics business, and our award-winning portfolio of injectables, devices and skin care products help health care professionals fuel confidence through aesthetic medicine.
Key Responsibilities:
Product Labeling Process:
- Manage the processing of all product labeling through the collaboration / review process, uploading attachments if needed, and ensuring final document meets standards for Document Control and applicable Labeling standards prior to release.
- Responsible for communicating document translations to the approved translation vendor(s) and ensuring they are appropriately released into the eQMS for applicable document revisions.
- Generating new InfoCards in the eQMS for Labels upon request.
- Own competency training for individuals required to review any labeling.
- Generate and/or review Quality Management System procedures.
- Proofread various documents to verify accuracy.
- Quality lead on new labeling projects.
- Implement new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels and improve operational efficiencies.
New Markets Activities
- Lead New Markets activities by reviewing, approving, and processing applicable labeling requirements.
Standards
- Assist with adherence to all Federal, State, and Local regulations as they apply to manufacture/distribution of medical devices, pharmaceuticals, OTC, and cosmetics.
NCR and CAPA
- Lead corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Inspections
- Support with federal, state, and local regulatory officials during regulatory inspections.
- Support in internal and vendor quality system audits as applicable.
Other Duties as Assigned
- Provides support to Quality Management personnel and performs other duties as assigned.
Education:
- Bachelor's Degree. Required
- BS/BA in Physical Science or Engineering. Preferred
Experience:
- 2 years in Medical Device or similar experience. Required
- 2 years in a quality role. Preferred
- ASQ Certification as a Quality Engineer or equivalent. Preferred
Knowledge Skills and Abilities:
- Operate Personal Computer, copying machines, printers, and scanners. Required
- Knowledge of quality systems, quality techniques, current regulatory requirements, and general problem-solving Required
- Thorough understanding and knowledge of documentation, records management, and change control for Quality System requirements in support of GxP regulations. Required
- Knowledge of labeling regulations and standards. Required
- Ability to work independently and make effective decisions. Required
- Ability to collaborate effectively with various departments. Required
- Ability to work effectively in a global environment. Required
- Strong attention to detail. Required
Benefits:
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more!
Your benefits and PTO start the date you're hired with no waiting period!
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 60-1.35(c)
Quality Assurance Engineering
