Quality Assoc I

Train on 1st shift, move to 3rd shift (weekend shift 5:15 am -7 pm)

• Conduct various Quality audits, identify and follow through with corrective actions, and maintain cGMP compliant documentation of such activities.
• Assist with Fragrance Inventory, Stability, Reserve, and USP Sampling Programs.
• Review Daily Batch Records and other quality production records for GDP, as needed.
• Assist writing, updating and/or revising policies, procedures, and forms.
• Log and report Q&S Violations and Actions.
• Placard and inspect Return Product with appropriate notifications or dispositions.
• Log plant Temperature and Humidity.
• Dry additive presence and quantified testing.
• Maintain cleanliness and organization of Quality Table, Binder shelves and other work areas following the principles of 5S; perform some minimal lab duties as needed.
• Inspect and approve various incoming raw materials (complete measurements and pin-hole testing)
• Must be able to conduct in-process audits by lifting range of 1lb to 50lb Bag products consistently and without restriction.
• Maintain Quality Hold Log and Disposition products as needed in accordance with Supervisor or Management input
• Quality Hold and Release of finished products-ERP and Placards
• Data Entry and assist with Monthly Reports by maintaining Incoming Raw Material inventory (Logbooks and Spreadsheets)
• Assist Supervisor with maintaining Daily Compliance Logs for Changeovers and Batch Records
• Make copies of paperwork cGMP errors and assist Production Supervisors with Training employees (cGMP and GDP)
• Assist with Fragrance Stability Program and maintain all Fragrance Retains
• Maintain clean and organized Batch Record Storage (Banker Boxes and Folders)

• Responsible for assisting with enforcement of safe working conditions and compliance with Giles’ Safety Policies.

Perform other Quality and Safety duties, as needed, based on the evolution of the company and the requirements of the department/position. Hours may vary due to production schedules.

EDUCATION and/or EXPERIENCE:

• 3 years’ work experience in Quality Assurance, Quality Control in an FDA regulated manufacturing environment.
• Ability to read, understand and retain information provided to employee via written or oral instructions along with use of great communication skills.
• Ability to meet deadlines, have strong personal time management skills and strong sense of urgency when completing tasks or assignments.
• Possess intermediate PC-based computer skills (Microsoft Word and Excel)
• High School Diploma or GED required. Previous work experience may be taken in lieu of education or degree