- 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, and 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).
- Perform additional duties as required.
- 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
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QA Document Control Specialist - South Bend, United States - Tri Pac, Inc.
Description
Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced QA Document Control Specialist for immediate addition to our fast growing team.Job Description:
The QA Document Control Specialist is responsible for maintaining the document and record control systems to meet Quality Management System requirements and is responsible for coordinating the issuance, revision, review and approval of SOP's and other documents. He/she must have excellent communication skills both verbally and written with a high degree of organization skills and have an excellent attention to detail, must be self-motivated and able to organize and prioritize multiple tasks. The successful candidate will also demonstrate an ability to work independently and as part of a team which is essential to success in this position.
Responsibilities:
Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.
Thank you for your interest and consideration of a career with Tri-Pac, Inc.
Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer
To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.
