Quality Assurance Supervisor - 2Nd Shift

JOB QUALIFICATIONS:

• High School diploma or equivalent
• 2-5 years experience in related field
• Knowledge of FDA/cGMP guidelines
• Computer literate in Microsoft Windows and Microsoft Office
• Working knowledge of Oracle and Agile
• Excellent analytical and problem-solving skills, with a focus on continuous improvement and process optimization
• Strong communication and interpersonal skills, with the ability to collaborate effectively
• Fluent in English, Spanish a plus
• Strong verbal and written communication skills

POSITION RESPONSIBILITIES:

• Oversee that all in-line checks for count, labeling, seal integrity and overall package quality are monitored accurately and within designated times as slated in our SOP
• Write NCMR’s as required
• Review Batch Record for missing entries and errors
• Ensure appropriate AQL were used and met
• Review daily, line operations to assure compliance with cGMP’s and SOP’s
• Review cleaning log books to assure the proper cleaning has taken place
• Investigate and discuss non-conformities with Inspectors
• Monitor QA personnel daily start and stop times
• Interact with company personnel as required to remedy problems related to packaging production or product quality and batch record reconciliation variances
• Assist in Process Validation as required
• Report any non-conformities or facility observations to the Manager
• Write and/or assist with deviation and investigation reports as necessary
• Assist Quality Department as needed

PHYSICAL REQUIREMENTS:

• Must be able to lift 50 lbs.
• Must be able to stand on feet all day