- Primary responsibility will be to build and enhance Workflows in all the Modules within MasterControl (Document, Training, CAPA, Deviations, Change Control, Vendor Management and Audits)
- Manage data structure.
- Create lifecycles within MasterControl to manage organizers, create templates, virtual folders, document numbering series and custom reports.
- Configure InfoCard types and Subtypes, Global Settings, Collaboration steps, Packet Types, as necessary to meet business needs.
- Troubleshoot errors. Design E-Forms/Fillable forms within MasterControl for use by personnel.
- Manage user licenses and user security settings.
- Conduct annual validation of MasterControl (PQ), submit subsequent report to MasterControl to meet deadlines.
- Train employees in use of MasterControl
- Write and revise Quality Systems and MasterControl related SOPs as necessary to maintain compliance.
- Review Manufacturing Batch Records (Drug Substance/Drug Product/Media Fills/ Prepared Media and Protocol Records). Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Records to be reviewed for accuracy, completeness, and compliance with effective SOPs.
- Review of Quality Control testing data against established specifications for compliance.
- Manage Deviations, Change Controls and CAPAs to closure.
- Conduct risk-based investigations using problem solving tools.
- Review equipment Calibration/PM records
- Review Computer System Validation records
- Represent Quality Assurance in Management Review Meetings, Material Review Board Meetings and in continual improvement projects as they relate to the Quality Management System and MasterControl.
- Participate in Regulatory Agency Inspections, as needed.
- Competency with electronic Quality Management System software (i.e., TrackWise, MasterControl, QT9, Qualio etc.)
- To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.
- Minimum Bachelor of Science degree in a scientific discipline
- Minimum two years in a similar Quality Assurance or Quality Systems role in the biologics or pharmaceutical industry a plus
- Familiarity with 21CFR Part 210, 211, ISO 9001 Std. and ICH guidelines is considered a plus.
- Familiarity with Quality Management Systems (e.g., ISO9001/ISO1485 Std.)
- Familiarity with Batch Records and controlled documentation
- Experience in aseptic processing and mammalian cell culture production considered a plus.
- Detail oriented
- Good verbal and technical writing skills
- Good interpersonal communication skills
- Must be open to occasional off shift and weekend work.
- Positive work attitude that supports teamwork and continuous improvement
-
QMS Administrator
1 week ago
Beacon Hill Exton, United StatesGeneral Responsibilities: · Do not pass up this chance, apply quickly if your experience and skills match what is in the following description. · Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality As ...
-
Shipping and Receiving Clerk mfg
4 days ago
Versant Health Philadelphia, United StatesClerk, Shipping and Receiving · Monday, Tuesday, Thursday, Friday & Saturday - 10am - 6:30pm · Shipping and Receiving Clerk · Who are we? · Versant Health is one of the nation's leading administrators of managed vision care, serving millions of our clients' members nationwide. We ...
-
Aurora Technologies Baumstown, United StatesAbout the Company · Since 1983, we have been supporting organizations from the public administration, industry, banking and insurance, or trade and service companies with the combined expertise of business consulting and IT consulting. Competent advice, optimal solutions, and pra ...
-
Director, Quality Management
6 days ago
PSI Services King of Prussia, United StatesCompany Description · We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the ...
-
Associate Account Director, Life Sciences
6 days ago
IQVIA Wayne, United StatesAssociate Account Director, Life Sciences · QualityMetric (QM) is looking for an experienced and high-energy AssociateAccount Director to support a portfolio of Patient-Reported Outcome based solutions and services as well as tech platforms. The primary function of this role is t ...
-
ORBIS INC Philadelphia, United StatesQMS Quality Control Specialist NSWCPD Code 00Q Philadelphia, PAResponsibilities: Position is for the Quality Control Specialist, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. This support will include suppo ...
-
Program Manager NSWCPD Code 00Q
1 week ago
Orbis Corporation Philadelphia, United StatesProgram Manager NSWCPD Code 00Q · Philadelphia, PA · Responsibilities: · Position is for the Program Manager, NSWCPD Code 00Q support, to lead team supporting Quality Assurance and Technical Administration Support services. This support will include supporting: Quality Managemen ...
-
Material Manager NSWCPD Code 00Q
2 days ago
ORBIS INC Philadelphia, United StatesMaterial Manager NSWCPD Code 00Q Philadelphia, PAResponsibilities: Position is for the Material Manager, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. This support will include supporting: Quality Managemen ...
-
BuildSubmarines Philadelphia, PA, United StatesQMS Quality Control Specialist NSWCPD Code 00Q · Philadelphia, PA · Responsibilities: · Position is for the Quality Control Specialist, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. This support will includ ...
-
Material Manager NSWCPD Code 00Q
6 hours ago
Orbis Corporation Philadelphia, United States Full timeMaterial Manager NSWCPD Code 00Q · Philadelphia, PA · Responsibilities: · Position is for the Material Manager, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. This support will include supporting: Quality M ...
-
Quality Management Coordinator II
3 days ago
Health Partners Plans Inc Philadelphia, United StatesTuesday, April 16, 2024 · Jefferson Health Plans is committed to the development of its staff and the achievement of their career goals. We are hiring a Quality Management Coordinator II to join our team We are committed to creating a community where everyone belongs, acknowledg ...
-
Registered Nurse
3 days ago
Coral Springs Rehabilitation and Nursing Center Wilmington, DE, United States Full timeCoral Springs Rehabilitation and Healthcare Center in beautiful Wilmington, DE is currently hiring for an Assistant Director of Nursing (ADON) The salary range for this position is $95,000-$115,000. Job Duties and Responsibilities: Assist the Director of Nursing in planning, deve ...
-
ORBIS INC Philadelphia, United StatesQuality Assurance Specialist for Command Level I Program NSWCPD Code 00Q Philadelphia, PAResponsibilities: Position is for the Quality Assurance Specialist, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administration Support services. Thi ...
-
registered nurse
5 days ago
Coral Springs Rehabilitation and Nursing Center Wilmington, DE, United StatesCoral Springs Rehabilitation and Nursing Center - Coral Springs Rehabilitation and Healthcare Center in beautiful Wilmington, DE is currently hiring for an Assistant Director of Nursing (ADON) · The salary range for this position is $95,000-$115,000. · Job Duties and Responsibili ...
-
Quality Assurance Manager
4 days ago
Millstone Medical Willington, United StatesCome join Millstone Medical Testing and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work · Millstone Medical Outsourcing, a fast growing, fast paced medical service provid ...
-
Registered Nurse
4 days ago
Coral Springs Rehabilitation and Nursing Center Wilmington, DE, US, United StatesCoral Springs Rehabilitation and Healthcare Center in beautiful Wilmington, DE is currently hiring for an Assistant Director of Nursing (ADON) · The salary range for this position is $95,000-$115,000. · Job Duties and Responsibilities: · Assist the Director of Nursing in planning ...
-
Registered Nurse
3 days ago
Coral Springs Rehabilitation and Nursing Center Wilmington, DE, United States Full timeCoral Springs Rehabilitation and Healthcare Center in beautiful Wilmington, DE is currently hiring for an Assistant Director of Nursing (ADON) · The salary range for this position is $95,000-$115,000. · Assist the Director of Nursing in planning, developing, organizing, implemen ...
-
ORBIS INC Philadelphia, United StatesJob Description · Quality Assurance Specialist for Command Level I Program NSWCPD Code 00Q · Philadelphia, PA · Responsibilities: · Position is for the Quality Assurance Specialist, NSWCPD Code 00Q support, to be part of team supporting Quality Assurance and Technical Administrat ...
-
Quality Assurance Manager
3 days ago
Millstone Medical Willington, United StatesCome join Millstone Medical Testing and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work · Millstone Medical Outsourcing, a fast growing, fast paced medical service provi ...
-
Quality Assurance Manager
4 days ago
Millstone Medical Willington, United StatesCome join Millstone Medical Testing and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work · Millstone Medical Outsourcing, a fast growing, fast paced medical service provid ...
QMS Administrator - Exton, United States - Beacon Hill
Description
General Responsibilities:
Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates and final product.
Responsibilities:
Assist the Quality Assurance Management in daily operations, as needed:
Computer Skills:
Education:
Experience:
Other Skills:
