Quality Assurance Specialist

4 weeks ago


South Bend, Indiana, United States Tri Pac, Inc. Full time
Job Title: Quality Assurance Specialist

Job Summary:

Tri-Pac, Inc., a leading contract development and manufacturing company, is seeking an experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for maintaining the document and record control systems to meet Quality Management System requirements.

Key Responsibilities:

- Issuance of document change control numbers, routing and tracking of new and revised documents for approval
- Filing of controlled documents and other documentation provided to QA
- Ensuring that all documents follow the change control procedure
- Review of documents for completeness, adherence to company guidelines for formatting, review of authorization for approvals
- Monitoring of status of in-process document changes to ensure timely completion
- Review all Packing Records completeness, customer specification, GDP guidelines for approval of product release
- Review and filing of Raw Material Inspection and Release forms
- Assisting in internal audits
- Support the establishment and improvement of quality systems and facilitate continuous improvements efforts of the Quality System
- Assist in quality audits, including document preparation and record retrieval
- Review and release raw materials, intermediate products and finished products
- Manage the approval and archival of SOP, WI, Process Flows, CAPA, OOS, deviations, nonconformance, complaints and investigation as required
- Create and manage product specification books for raw materials and finished products, manage the change control process for specification updates and assist with on-boarding documentation of new products
- Support validation and qualification of process equipment, lab equipment, stability chambers, cleaning, and utilities
- Manage New Equipment Asset lists and assign numbers for all new equipment added to the facility
- Manage vendor documentation (Vendor Qualification Reports, CoAs, SDS)

Requirements:

- BA, BS Degree in Business
- Proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook), Adobe Acrobat, and SAP
- Five years' experience in GMP environment with relevant Quality Assurance/Compliance experience
- Knowledge of FDA 210, 211 and ISO 13485, 9001, 22716 preferred

What We Offer:

- Competitive Salary/ Pay & Packages
- Vacations
- Insurance
- 401K
- Life Insurance
- Disability (Long term/ Short term) and Continuous Training

About Us:

Tri-Pac, Inc. is a contract development and manufacturing company specializing in liquid and aerosol filling for personal care and pharmaceutical marketers. We are committed to providing high-quality products and services to our customers.

Equal Employment Opportunity:

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer

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