- 2+ years of Document Control & Reporting Experience,
- Veeva experience preferred
- Technical troubleshooting
- Self motivated, independent, great communication
- Experience working cross-functionally
- Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
- May write and revise document control procedures including participating in the development and roll-out of document control tools.
- Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
- Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
- Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
- Generate document management system reports for Quality Council metric reporting.
- Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
- Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
- Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker - Associate Director, QA Training &
- Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
- Strong communication and customer service skills.
- Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Possess project management skills.
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- Strong knowledge of cGMPs and domestic regulatory requirements.
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
- Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
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QA Document Control Associate
Found in: Lensa US 4 C2 - 6 days ago
Piper Companies Summit, United StatesPiper Companies · is currently seeking a · QA Document Control Associate · for an opportunity in · Summit, New Jersey (NJ), · to join a global biopharmaceutical company delivering life-saving medicines to patients with serious diseases. · Responsibilities of the QA Document ...
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Vertellus Berkeley Heights, United StatesCompany Overview · Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and ...
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Document Control Specialist
Found in: Lensa US 4 C2 - 4 days ago
Vertellus Berkeley Heights, United StatesCompany Overview · Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and ...
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QA Associate Specialist – Document Control
Found in: Appcast US C2 - 3 days ago
Pyramid Consulting, Inc Summit, United StatesImmediate need for a talented QA Associate Specialist – Document Control. This is a 12+ months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay R ...
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QA Associate Specialist Document Control
Found in: Lensa US 4 C2 - 3 days ago
Pyramid Consulting Summit, United StatesImmediate need for a talented QA Associate Specialist Document Control. This is a 12+ months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay R ...
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QA Associate Specialist Document Control
Found in: Lensa US 4 C2 - 7 hours ago
Aequor Technologies Summit, United StatesJob Description: Top Skills: · - 2+ years of Document Control & Reporting Experience, · - Veeva experience preferred · - Technical troubleshooting · - Self motivated, independent, great communication · - Experience working cross-functionally · Position Summary: · The Quali ...
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QA Associate Specialist Document Control
Found in: Lensa US 4 C2 - 2 days ago
Sunrise Systems Summit, United StatesTop Skills: · 2+ years of Document Control & Reporting Experience, · Veeva experience preferred · Technical troubleshooting · Self motivated, independent, great communication · Experience working cross-functionally · Position Summary: · The Quality Assurance Document Con ...
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Document Controller
Found in: Indeed US C2 - 4 days ago
Airswift North America Brooklyn, United States Full time*Our client, a major Oil & Gas company is seeking a Document Controller* *to work within their facilities located in Brooklyn, TX for a 12-month contract (possible to extend).* · The professional will be responsible for maintaining organized documentation to demonstrate complianc ...
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Found in: beBee S2 US - 6 days ago
Mace New York City, United States Full timePosition Status: This opportunity is for a secured role that is due to commence in March subject to approval. If you would like to be considered as we progress with this position, please click to apply. · At Mace, our purpose is to redefine the boundaries of ambition. We believe ...
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Document Control Analyst
Found in: Lensa US 4 C2 - 5 days ago
Bayside Solutions Newark, United StatesDocument Control AnalystW2 ContractSalary Range: · $83,200 - $93,600 per yearLocation: · Newark, CA - Onsite RoleDuties and Responsibilities:Coordinate and control technical documentation in various formats that support the company's products.Manage files, regardless of medium, ...
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Document Control Analyst
Found in: Lensa US 4 C2 - 4 days ago
Bayside Solutions Newark, United StatesDocument Control AnalystW2 ContractSalary Range:$83,200 - $93,600 per yearLocation:Newark, CA - Onsite RoleDuties and Responsibilities:Coordinate and control technical documentation in various formats that support the company's products.Manage files, regardless of medium, through ...
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Document Controls Manager
Found in: Lensa US 4 C2 - 16 hours ago
Public Service Enterprise Group Inc Newark, United StatesRequisition: 78399 · PSEG Company: Public Service Electric & Gas Co. · Salary Range: $ 101,600 - $ 160,900 · Incentive: PIP 15% · Work Location Category: Hybrid · PSEG operates under a Flexible Work Model where flexible work is offered when job requirements allow. In support ...
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Document Controls Manager
Found in: Lensa US 4 C2 - 3 days ago
PSEG Newark, United States**Requisition** : 78399 · **PSEG Company:** Public Service Electric & Gas Co. · **Salary Range** : $ 101,600 - $ 160,900 · **Incentive** : PIP 15% · **Work Location Category** : Hybrid · PSEG operates under a Flexible Work Model where flexible work is offered when job requirement ...
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Found in: Appcast US C2 - 6 days ago
Atlas New York, United StatesAtlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in Austin, TX, Atlas currently has over 3,500 employees in offices throughout the US. It ...
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Document Control Associate
Found in: Lensa US 4 C2 - 1 day ago
Kelly Services, Inc. Totowa, United StatesKelly Services, Inc. - JobID: 55AEB38E06F948A68C2D498E2FAD4698 [Office Clerk / Admin Assistant] Kelly Services is in Immediate need of a relaible Document Control. Our steady client is experiencing amazing growth and has both part-time and full-time positions available now. Dutie ...
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Assistant Document Control
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Global Channel Management Somerville, United StatesJob Description: · Assistant Document Control needs 1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry · Assistant Document Control requires: · BA/BS degree or equivalent experience is preferred. · 1 to 3 years of relevant experience in the phar ...
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Found in: Lensa US 4 C2 - 5 days ago
ARCADIS New York, United StatesJob Description · Arcadis is seeking a Document Controls Manager for a large project in New York. · Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. · We are more than 36,000 people, in o ...
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Document Control Manager
Found in: Lensa US 4 C2 - 4 days ago
Atlas New York, United StatesAtlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in Austin, TX, Atlas currently has over 3,500 employees in offices throughout the US. It ...
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Document Control Manager
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Bechtel New York, United StatesRequisition ID: 276097 · Relocation Authorized: None · Telework Type: Full-Time Office/Project · Work Location: New York, NY · Salary Range: $105,060 - $161,700 annually (Determined by function, education, experience, and qualifications of the applicant. A 15% salary uplift is ...
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Document Control Coordinator
Found in: ZipRecruiter Test10S US C2 - 3 days ago
First Class Moving Systems Bound Brook, United StatesJob Description · Job DescriptionSalary: $20-$24hr DOE · This is a seasonal position lasting from April to August/September · Document Control Coordinator · At First Class Moving Systems, an agent for North American Van Lines, our mission is to provide quality-focused, customer-c ...
Quality - QA Associate Specialist - Document Control - Summit, United States - HonorVet Technologies
Description
Job Description:
Top Skills:
Position Summary:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting
Duties/Responsibilities:
Primary responsibilities include:
Document Control Education:
Bachelor's degree or equivalent
Experience Basic Qualifications:
dditional Job Requirements:
None
