Hubot | Tri Pac, Inc. CDMO
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 SOP’s and other documents. The candidate must have excellent communication skills, high organization and attention to detail, be self‑motivated, able to organize and prioritize multiple tasks, work independently and as part of a team.
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 all documents follow the change control procedure.
Review of documents for completeness, adherence to company guidelines for formatting and review of authorization for approvals.
Monitoring status of in‑process document changes to ensure timely completion.
Review of 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 establishment and improvement of quality systems and facilitate continuous improvement 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 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 onboarding 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 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 QA/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.
Tri‑Pac, Inc.
is an Equal Employment Opportunity / affirmative action employer.
#J-18808-Ljbffr
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 SOP’s and other documents. The candidate must have excellent communication skills, high organization and attention to detail, be self‑motivated, able to organize and prioritize multiple tasks, work independently and as part of a team.
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 all documents follow the change control procedure.
Review of documents for completeness, adherence to company guidelines for formatting and review of authorization for approvals.
Monitoring status of in‑process document changes to ensure timely completion.
Review of 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 establishment and improvement of quality systems and facilitate continuous improvement 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 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 onboarding 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 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 QA/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.
Tri‑Pac, Inc.
is an Equal Employment Opportunity / affirmative action employer.
#J-18808-Ljbffr