Hubot | Tri Pac, Inc. CDMO
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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
Document Control Specialist
for immediate addition to our fast growing team.
Job Description The Document Control Specialist is responsible for maintaining the document and record control systems to meet Quality Management System requirements and coordinating the issuance, revision, review and approval of SOPs and other documents. He/she must have excellent communication skills both verbally and written, a high degree of organization, attention to detail, be self‑motivated and able to 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
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
Experience and/or Education
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
Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/Short term) and Continuous Training.
Equal Employment Opportunity Tri-Pac, Inc. is an Equal Employment Opportunity / Affimative Action Employer.
Recruitment Policy 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.
Location: South Bend, IN
Job Type: Full‑time
Seniority: Associate
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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
Document Control Specialist
for immediate addition to our fast growing team.
Job Description The Document Control Specialist is responsible for maintaining the document and record control systems to meet Quality Management System requirements and coordinating the issuance, revision, review and approval of SOPs and other documents. He/she must have excellent communication skills both verbally and written, a high degree of organization, attention to detail, be self‑motivated and able to 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
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
Experience and/or Education
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
Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/Short term) and Continuous Training.
Equal Employment Opportunity Tri-Pac, Inc. is an Equal Employment Opportunity / Affimative Action Employer.
Recruitment Policy 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.
Location: South Bend, IN
Job Type: Full‑time
Seniority: Associate
" #J-18808-Ljbffr