Quality Assurance Auditor

Company Overview

FillTech USA is a contract manufacturer delivering exceptional formulation and manufacturing services to emerging and established care brands, major retailers and distributors. The company has a 25-year history of converting the innovations of its customers into finished branded products that are ready to be sold through various channels to end user consumers.

**1st Shift Schedule Monday - Thursday 5:00am - 3:30pmpm / Friday OT if needed

**2nd Shift Schedule Monday - Thursday 3:15pm - 1:45am / Friday OT if needed

Job Description:

REQUIREMENTS:

• Must have High School Diploma or GED
• 5 years of experience in high volume manufacturing, previous experience within a cGMP compliant facility preferred
• 2-3 years of experience auditing product, processes, building/facility and cGMP compliance.
• Ability to fluently speak, read, write in English and ability to follow instructions and Standard Operating Procedures
• Excellent Written and verbal communication skills, ability to complete audit reports
• Basic math skills, ability to count and take accurate inventory of materials
• Computer Proficiency in Microsoft (MS) Office and other software; experience with Minitab a plus.
• Excellent time management, organizational skills, problem-solving skills, and attention to detail
• Good Documentation skills
• Ability to work effectively in a fast-paced, rapidly changing environment independently with little guidance or as a member of a team
• Ability to stand or walk for extended periods of time; ability to bend and to lift up to 50 lbs.
• Flexibility to work at the main location or at an off-site facility located in Rockwell, NC.

JOB DESCRIPTION:

The Quality Assurance Auditor will perform their role as follows:

Reports to the Quality Control Manager

• Perform quality audits of in-process product, finished products, and operations processes (i.e., quality line clearance and oversight) activities, including verification of bulk product, packaging components and labels, as well as batch status confirmation. Conducts investigations of non-conformances.
• Perform material inspection of in-process production activities, including checks for quality defects and execution of process per approved batch records. Audit and confirm the addition of API materials. Work closely with Production to ensure the oversight and maintenance of cGMP documentation and processes.
• Serves as key communication liaison between quality control and operations, attending meetings and communicating testing priorities, OOS results and follows-up with status of any previous OOS.
• Communicates customer complaints and provides On-Point-Lessons and daily bulletins to the all-operational groups until complaints are closed.
• Participates and audits rework activities.
• Perform additional inspections and investigations according to AQL standards and verify against established specifications. Collects data to be used in further disposition.
• Documents Non-conformances according to standard operating procedures, placing materials on hold or in quarantine for further disposition, and assisting with investigations of non-conformance. Collects data on non-conforming packaging materials and communicates statistics to quality management for follow-up and invoicing.
• Assist with Batch Record review activities, as needed
• Maintains cleanliness of work area and assists with cleaning of other areas within the facility
• Audits facility against FDA cGMP guidelines and other regulatory (such as Health Canada and TGA Australian compliance) or customer requirements. Documents audit results by completing written and computerized reports, logs, and files
• Maintains a safe and healthy work environment by following standards and procedures
• Complies with all regulatory/in-house requirements which may include but not limited to safety, housekeeping, warehousing, production, waste, cGMP and cGDP requirements
• Assists QC Chemist and other quality team members and serves as back-up for Chemists, as needed.
• Calibrates and uses scales, thermometers, viscometers, and other measuring devices.
• Perform additional job-related duties, as required

Note: This job description is not intended to be all-inclusive. The employee may perform other related duties as required to meet the ongoing needs of the organization.

Job Type: Full-time

Pay: From $18.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Manufacturing: 3 years (Required)

Ability to Commute:

• Rockwell, NC (Required)

Work Location: In person

Salary : $18