Quality Documentation Specialist

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.

Job Description:

- Primary responsible for the thorough review of all Master Batch Records and Master Packaging Records. Communicate batch release, quarantined, and rejected materials to management and to sales teams.

- Ensure adherence with GMPs, SOP's and Good Documentation Practices. Provides SOP and GDP training to other teams as necessary.

- Ensure all records comply with FDA< Canadian, and TGA Market Authorization prior to finished product release.

- Review LIR, IRs, Change Controls, and Rework Procedures associated with batches prior release.

- Collaborate with other teams, management, in conducting formal investigations to identify root cause of non-conformance issues, and prepare investigation reports as needed.

- Collaborate with Quality Control for in-house testing and outside third-party laboratories testing results. Prepare Certificates of Analysis and Certificate of Conformance based upon batch record review and quality control results.

- Prepare and provide export-related materials, such as Canadian or Australia, to customers and outside agencies.

- Create and manage equipment and process logbooks for each department.

- Audits facility against FDA cGMP guidelines and other regulatory (such as Health Canada and TGA Australian compliance) or customer requirements.

- Complies with all regulatory/in-house requirements which may included but not limited to safety, housekeeping, warehousing, production, waste, cGMP requirements.

Requirements:

- Must have High School Diploma or GED

- Bachelor's Degree or Associate Degree in science related field or 4 years of related work experience in lieu of degree.

- 3+ years of experience in high volume manufacturing, previous experience within a cGMP or another regulated environment preferred.

- Basic math skills, ability to count and reconcile inventory of materials.

- Excellent Documentation skills; experience with GDP's a must.

- Primarily staffed at the main facility on first shift with the flexibility needed to adjust schedule with advance notice depending on department needs.

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 $17.00 per hour

Expected hours: 40 per week

Benefits:

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

Experience level:

• 3 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Manufacturing facility

Experience:

• Manufacturing: 3 years (Required)

Ability to Commute:

• Rockwell, NC (Required)

Work Location: In person