Qa Document Control Specialist
By Tri Pac, Inc. At South Bend, IN, United States
Manage vendor documentation (Vendor Qualification Reports, CoAs, SDS).
Manage the approval and archival of SOP, WI, Process Flows, CAPA, OOS, deviations, nonconformance, complaints and investigation as required.
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.
Five years’ experience in GMP environment with relevant Quality Assurance/Compliance experience
Knowledge of FDA 210, 211 and ISO 13485, 9001, 22716 preferred
Qa Specialist Ii - Document Control
By United Therapeutics At , Silver Spring
2+ years of experience in using an electronic document management system (eDMS) preferably MasterControl
Experience using a document management system preferably MasterControl experience
Effective time management and interpersonal skills
Manage the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement)
Administer the MasterControl electronic Document Management System
Process and execute documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
Qa Document Control Specialist Contractor- Remote
By Cytokinetics At South San Francisco, CA, United States
General administrative responsibilities in working with electronic document management systems
This position is responsible for actively supporting the quality and management of controlled documents (SOPs, Work Instructions, Forms, Development Reports, Templates)
Experience and expertise in Word document creation, editing, and formatting required
5+ years experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area with experience in Document Control
Advanced skills in MS Office Suite, particularly in Word document processing and formatting
Provide hands on expertise in formatting and editing of controlled documents
Qa/Document Control Specialist
By Boccard At Houston, TX, United States
Perform all duties related to his/her position or assigned by the immediate manager.
A minimum of 3 years experience on quality control is required.
Verify that only the last revision documentation, procedures, submittals, etc., are distributed to all locations and involved parties concerned including sub-contractors.
Prepare all documents based on the quality procedures for internal and external audit.
Transmittal of drawings, quality procedures, related documentation to the concerned contractors, departments, vendors and client.
Submitting technical documents for review and approval.
Document Control Specialist (Mdc Specialist) - Abiomed
By Johnson & Johnson At Danvers, MA, United States
Ensure that approved compliance policies, procedures and requirements are implemented or in place, as appropriate.
Review and collaborate with content creators to ensure their projects, programs or marketing activities consistently meet compliance requirement standards.
Bachelor's Degree and minimum of 2 years of experience or 5 to 7 years equivalent work experience.
Strong organizational skills; must be detailed-oriented.
Must have powerful editing/proofreading skills.
Results driven, self-motivated, and solutions-oriented ability to manage assigned tasks in an assertive, efficient, and timely manner.
Labeling Specification Specialist Jobs
By Planet Pharma At United States
2+ years of labeling experience within medical device/pharma/food industry
Ensures that labeling art film and plate proofs meet all medical legal and regulatory requirements.
***Compensation within this range will be commensurate with level of experience***
Monitors changes in labeling regulations in the US and/or abroad.
Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
Monitor evaluate and recommend improvements to labeling processes quality systems tools and/or policies.
Labeling Specialist Jobs
By Jobot At Irving, TX, United States
Manage labeling projects from planning to execution, ensuring accuracy and compliance with regulatory requirements.
Knowledge of regulatory requirements for labeling in the Nutrition industry.
Work with manufacturers to ensure compliance with US dietary supplement and food product labeling requirements.
Ability to work in a fast-paced environment and manage multiple projects simultaneously.
Strong communication and collaboration skills.
Collaborate with internal cross-functional teams to ensure labeling timelines align with product launch timelines.
Labeling Specialist Jobs
By Zimmer Biomet At , Warsaw, 46580, In
Initiate change requests for new and revised labeling, work with Labeling Coordinators to create, maintain, and implement compliant labeling.
Good understanding of how labeling systems communicate with other business systems
Ability to lead team efforts on labeling projects.
Able to perform work with a high degree of accuracy and minimal supervision.
Commitment to learn and stay abreast of medical devices regulations. Understand the overall business environment, the orthopedic industry, and the marketplace.
* Please note, this position is a hybrid role, that sits partially onsite, in Warsaw, Indiana.
Labeling Specialist Jobs
By Gowan USA At , Yuma, Az
Experience in the ag-chem or other chemical industry helpful to understand the critical nature of labeling accuracy and requirements.
This position does not require creativity design experience. It requires more attention to details and organizational skills.
Attention to detail skills a must!
Ability to learn new technology applications. Adobe Creative Suite (InDesign, Illustrator) knowledge a plus.
Clerical and critical thinking skills.
Creates California Printer’s Proofs for Regulatory Specialists submissions.
Qa Document Control Coordinator
By Dairy Farmers of America At Portales, NM, United States
Knowledge of and skill working with computer software such as Word, Excel, Access and Power Point
Inspect the facility and paperwork for compliance to GMP, SQF, and Regulatory requirements
Certification and/or License – SQF Practitioner Certification and HACCP Certification required within 1 year
Demonstrated ability to manage multiple priorities and functions
Maintain DFA document control process
Review completed production, sanitation, and quality records
Marketing Document Control Specialist (Mdc Specialist) - Abiomed
By Johnson & Johnson At , Danvers, Ma
Ensure that approved compliance policies, procedures and requirements are implemented or in place, as appropriate.
Review and collaborate with content creators to ensure their projects, programs or marketing activities consistently meet compliance requirement standards.
Bachelor's Degree required and 2 years’ experience preferred.
Strong organizational skills; must be detailed-oriented
Must have powerful editing/proofreading skills.
Results driven, self-motivated, and solutions-oriented ability to manage assigned tasks in an assertive, efficient and timely manner.
Qa Document Specialist Jobs
By ZEISS Group At , Chesterfield, Mo
Help manage documentation overhaul projects
0-3 years experience in a relevant field
Strong communication skills, both written and spoken
Experience in the medical device field, or another regulated industry
Review and approve non-DMS documents (QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, Calibration Records, Training Records, Customer Complaints, Nonconformances, etc.)
Help review document changes helping to determine possible impact to regulatory and operational compliance
Qa Document And Training Manager
By NuWest Group At Washington, United States
· Knowledge of QA systems and GCP/GLP compliance requirements
Ensure training requirements are identified and implemented.
GCP/GLP QA Document and Training Manager
· 7+ years’ experience in biopharmaceutical industry
· Prior Veeva QualityDocs and/or Training implementation experience or administrator role
· Strong oral and written communication skills needed
Labeling Specialist - Remote
By Proclinical Staffing At Cambridge, MA, United States
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.
Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.
Qa Supervisor - Labeling/Packaging
By Agenus At Berkeley, CA, United States
Site Quality Systems Management: CAPA, Change Control, Deviations, Investigations, Risk Assessment, and Vendor Change Notification with emphasis on labeling/packaging operations
Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
Experience with labeling/packaging operations preferred
Experience with supervision and training of personnel preferred
Working knowledge of GMP principles with respect to FDA and EMA regulations
Working knowledge and technical understanding of the manufacture and testing of biologics
Qa Specialist Jobs
By Kashiv BioSciences, LLC At , Piscataway, 08854, Nj
Provide back up for other Quality Assurance Specialist responsibilities. Perform other duties and responsibilities as delegated by Quality Management.
Manage a broad spectrum of projects to support the needs of Quality Management.
Working knowledge of Deviation, CAPA, Change Control, Validation/Qualification (IQ/OQ/PQ) is desired.
Good organizational skills and detail oriented. Must be able to effectively manage time to complete assignments.
Previous experience in cGMP pharmaceutical manufacturing environment is desired.
Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
Qa Specialist Jobs
By Intellectt Inc At Buffalo Grove, IL, United States
Need experience in Batch record review in the medical field.
At least 3 years' experience in the med device field.
Open to Associates degree for 5 yrs. med device experience
There are 6 factories on site; Each factory has its own batch records.
Their primary responsibility will be to view batch records.
Support sometimes in Non-conformances and CMRs
Associate Specialist, Labeling Jobs
By Edwards Lifesciences At Irvine, CA, United States
Bachelor's Degree with 1 year of related experience Required
Previous experience working in a medical/pharmaceutical FDA regulated industry
Excellent written and verbal communication skills and interpersonal relationship skills
Basic knowledge of medical device documentation development activities
Knowledge of ECR and Ignite processes
Good computer skills including usage of MS Office Suite
Qa Specialist Jobs
By Shift Paradigm At Austin, TX, United States
Ensure that proper checks are done for each email campaign based on the project requirements outlined in the project documentation
Strong communication skills - both written and verbal
Ensure that email campaigns are compliant in the following areas:
Verify images and copy are correct according to documentation, and that copy is free of obvious typos or grammatical errors
Test functionality & verify correct destination URL and tracking codes
Check for business critical rendering errors across designated email environments
Gxp Qa Specialist Jobs
By Johns Hopkins University At , Baltimore, 21287, Md $94,710 a year

Special Knowledge, Skills, or Abilities:

Equipment, Machine, or Tool Requirements:

Are you looking for an exciting opportunity to join a growing team as a QA Document Control Labeling Specialist? We are looking for a detail-oriented individual to join our team and help ensure the accuracy and quality of our documents. You will be responsible for reviewing documents for accuracy, labeling them correctly, and ensuring that all documents are up to date and compliant with industry standards. If you have an eye for detail and a passion for quality assurance, this could be the perfect job for you!

A Quality Assurance (QA) Document Control Labeling Specialist is responsible for ensuring that all documents related to the production and distribution of products are accurately labeled and tracked. This includes ensuring that all documents are properly labeled and stored, that all documents are up to date, and that all documents are compliant with applicable regulations.

What is QA Document Control Labeling Specialist Job Skills Required?

• Strong attention to detail
• Excellent organizational skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite
• Knowledge of quality assurance principles
• Knowledge of document control systems

What is QA Document Control Labeling Specialist Job Qualifications?

• Bachelor’s degree in a related field
• At least two years of experience in a related field
• Knowledge of applicable regulations and standards
• Ability to interpret and apply regulations and standards
• Ability to work with a variety of stakeholders

What is QA Document Control Labeling Specialist Job Knowledge?

• Knowledge of document control systems
• Knowledge of quality assurance principles
• Knowledge of applicable regulations and standards
• Knowledge of labeling requirements

What is QA Document Control Labeling Specialist Job Experience?

• At least two years of experience in a related field
• Experience in document control and labeling
• Experience in quality assurance

What is QA Document Control Labeling Specialist Job Responsibilities?

• Ensure that all documents related to the production and distribution of products are accurately labeled and tracked
• Ensure that all documents are properly labeled and stored
• Ensure that all documents are up to date
• Ensure that all documents are compliant with applicable regulations
• Monitor document control systems for accuracy and compliance
• Maintain records of document control activities
• Assist with quality assurance audits
• Assist with the development of labeling requirements
• Assist with the development of document control systems
• Provide training and guidance on document control and labeling requirements