Responsibilities:

• Creates finished products, bulk products and raw material specifications sheets in accordance to “ The Code of Federalregulations Title 21- Food and Drugs §111.70”
• Supervises all the complaints process including complaint investigations, the supplier quality program as well as the Material Review Board process.
• Supervises the logging, routing, follow-up, implementation, and closure of all change controls.
• Creates and revises SOP’s, approves Material Reviews and Dispositions (MRD’s) and change controls, as wellas assists with any necessary training and implementation of Quality procedures.
• Performs any other related duties as may be required by the Manager.
• Supervises, facilitates, and manages the change control process across Vytalogy sites.
• Assists the department with any tasks related to cGMP implementation and
• Supervises the activities relating to Deviations/ CAPA and non-conformance tracking and follow-ups.
• Ensures the Workfront label review process runs smoothly in accordance with 21 CFR111.
• Coordinates with the Consumer Affairs team on Non-serious Adverse Events and follows up on the non-SAERs forwarded by Consumer Affairs to QS.
• Assist with the CM incoming quality inspections review and final lot release.
• Ensures the reviews and coordination of vendor raw material CofA’s, product specifications, MSDS, and otherproduct-related information from vendors, as instructed by supervisor/manager.
• Manages/coordinates with the Consumer Affairs on the investigation of on-serious Adverse Event Reports, and other customer
• Supervises the activities of QS Associate staff across Vytalogy.
• Manages/Assist with the Document Controls DCR/SOPs/Training Documentation.

• Experience with regulatory inspections would be
• BA/BS in Chemistry or related discipline with 2 to 4 years’ experience in a QA/QCenvironment 1 years’ experience in a QA/QC environment
• Ability to work in a fast pace environment and to value the importance of teamwork
• Excellent analytical and problem-solving skills and written and verbal
• Knowledge/ Experience in cGMP and other pertinent regulations
• CGMP and regulatory knowledge of relevant FDA and global stability