Top 10 Quality specialist Jobs in Danbury, Ct

Quality Document Management Specialist II
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- 18 years or older
- Pass drug screening
- Mid-level
5d
AI Data Quality Specialist - AI Trainer
DataAnnotation —Bridgeport, CT
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
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Senior Quality Systems Specialist
BIOWAVE CORPORATION —Westport, CT
- $75,000 - $80,000 a year
- Overtime
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
- Health insurance
- Dental insurance
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QRM - Quality Specialist - ER&I - C_MAT
Deloitte —Stamford, CT
- $95,600 - $188,400 a year
- Full-time
- Bachelor of Science
- Master's degree
- Analysis skills
QRM - Quality Specialist - FSI - C_MAT
Deloitte —Stamford, CT
- $95,600 - $188,400 a year
- Full-time
- 6 years
- Bachelor of Science
- Mid-level
Validation Specialist
Katalyst Healthcares & Life Sciences —Bridgeport, CT
- Contract
- 5 years
- Engineering
- English
Quick Apply

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Quality Document Management Specialist II

BI Pharmaceuticals, Inc. -
Ridgefield, CT

Apply Now

Job Details

Full-time
5 days ago

Qualifications

Customer communication
Document control experience within pharmaceutical industry
Conflict management
Technical writing
Productivity software
Cross-functional collaboration
Cross-functional communication

Full Job Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Quality Document Management Specialist II will act as a Document Management Specialist for SOPs, other GxP documents, and archived records generated by the Development organization. This role will conduct activities supporting document management and archiving operations. The incumbent will provide guidance to colleagues on the processes and systems for document management and archiving as well as identify, interpret, and define document management needs and improvements that fulfill compliance and business requirements.

Duties & Responsibilities

Contributes to the management of the on-site archive.
Accountable for the receipt, indexing, storage, retention, and retrieval of records submitted to the archive.
Responsible for conducting and refining processes that enable effective preservation, access to, and security of digital and paper archives.
Identifies and proposes process improvements.
Provides controlled document support by managing the document life cycle in the electronic Document Management System (eDMS).
Manages workflows, facilitates the use of appropriate document types and technical formats.
Executes the periodic review process.
Collaborates with document owners and cross-functional teams to ensure quality standards are met.
Regularly communicates with internal customers to keep them informed.
Provides expertise in records management and preservation of electronic records.
Participates in working groups and task forces related to electronic records and digital information.
Automates and improves processes using AI/digital tools.
Serves as a Subject Matter Expert (SME) on eDMS, advises document owners on good documentation practices and Boehringer Ingelheim standards, and executes various document management service components.
Provides end user training on document management processes and systems.
Contributes to proposals for enhancements and testing to implement additional functionality within eDMS.
Participates in and contribute to inspection readiness activities.
Acts as a point of contact for audit questions related to the archive and document management during internal, corporate, and regulatory authority inspections.
Resolves straight forward observations noted during audits/inspections.
Support and maintain training assignments and documentation within the Learning Management System (LMS) to ensure accurate and timely capture of training events and records.
Create and maintain training curriculums/roles within the Learning Management System including providing quality checks and assisting with KPI generation.
Monitor and triage the training mailbox, providing customer support for questions and escalations when needed.

Requirements

Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Bachelor’s degree from an accredited institution with three-plus (3+) years or equivalent experience in related field.
Demonstrates knowledge of document lifecycle management and archiving processes and systems including regulatory and compliance requirements.
Previous experience in pharmaceutical industry and knowledge of GLP/GMP regulations is a plus.
Proficiency in Microsoft Office 365 tools and knowledge of other tools (e.g. Power Apps etc.).
Requires minimal supervision in applying new technology and concepts and evaluating and implementing new electronic tools.
Demonstrates ability to detect problems and define solutions.
High degree of attention to detail.
Ability to find errors or inconsistencies that others may miss.
Demonstrates the ability to write standard documents.
Excellent written and verbal communication skills.
Ability to communicate outside of Development to Legal, IT and other functions.
Excellent conflict resolution and negotiation skills.

Eligibility Requirements :

Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Desired Skills, Experience and Abilities

Experience working with a Learning Management System (LMS) (e.g., SuccessFactors, Cornerstone, SumTotal, etc.)
Experience working with an electronic Document Management System (eDMS) (e.g. Veeva Vault Quality)

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quality specialist jobs in danbury, ct

Quality Document Management Specialist II

AI Data Quality Specialist - AI Trainer

Senior Quality Systems Specialist

QRM - Quality Specialist - ER&I - C_MAT

QRM - Quality Specialist - FSI - C_MAT

Validation Specialist

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