Tri-Pac INC
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Document Control Specialist
role at
Tri-Pac INC
1 week ago Be among the first 25 applicants
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, meticulous attention to detail, self‑motivation, and the ability to organize and prioritize multiple tasks. The successful candidate will 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 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/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. Work where you are HAPPY!
www.tri-pac.us
Thank you for your interest and consideration of a career with Tri-Pac, Inc.
Tri-Pac, Inc. is an Equal Employment Opportunity / Affinity Action Employer.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Administrative
Industries Warehousing
Referrals increase your chances of interviewing at Tri-Pac INC by 2x
Get notified about new Document Control Specialist jobs in
South Bend, IN .
South Bend, IN $77,054.00-$115,582.00 3 weeks ago
South Bend, IN $31,200.00-$32,219.20 2 weeks ago
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Document Control Specialist
role at
Tri-Pac INC
1 week ago Be among the first 25 applicants
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, meticulous attention to detail, self‑motivation, and the ability to organize and prioritize multiple tasks. The successful candidate will 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 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/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. Work where you are HAPPY!
www.tri-pac.us
Thank you for your interest and consideration of a career with Tri-Pac, Inc.
Tri-Pac, Inc. is an Equal Employment Opportunity / Affinity Action Employer.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Administrative
Industries Warehousing
Referrals increase your chances of interviewing at Tri-Pac INC by 2x
Get notified about new Document Control Specialist jobs in
South Bend, IN .
South Bend, IN $77,054.00-$115,582.00 3 weeks ago
South Bend, IN $31,200.00-$32,219.20 2 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr