BioSpectra, Inc. · 20 hours ago
QA Technician I, Majestic
Bangor, PA
Full-time
Onsite
New Grad, Entry LevelBioSpectra, Inc. is a company focused on quality assurance in the production of materials. The QA Technician I, Majestic is responsible for ensuring quality standards in material disposition, conducting inspections, and maintaining compliance with established procedures at the Bangor, PA facility.
ChemicalManufacturingPharmaceutical
Responsibilities
Issues analytical summary sheets for all products manufactured or packaged at BioSpectra's Bangor, PA facility
Issues Batch Records including all documentation for accountability of labels, seals, lot number assignment associated with the released of the manufactured product
Reviews and approves Batch Records (for non-GMP and sample lots) including all documentation review associated with the release of the manufactured product
Issues Certificate of Analysis for Finished Goods Shipments
Notifies management of any non-conforming events and assists with writing or reviewing Investigation Reports
Communicates any quality related requirements or findings to applicable department staff to ensure the correction or prevention of non-conforming events
Performs Finished Good Inspection/QA Approval prior to Finished Good Shipments at BioSpectra's Bangor, PA facility
Performs review of Pest Control reports for Bangor, PA facility
Performs review of Temperature and Humidity Monitoring Assessments
Performs quality review of Preventative Maintenance documentation
Performs quality review of Maintenance Work Orders
Inspects incoming Components and Raw Materials
Approves and monitors the usage of regulated inventory in Sage ERP system
Provides the placards detailing the disposition of material for placement in the facility Warehouses
Recommends modifications of existing quality or production standards to achieve optimum quality within limits of manufacturing capability
Ensures Quality records are accurate, approved and in compliance with cGMP standards
Ensures that the facility is functioning in accordance with established quality policies and procedures through document review and approval, quality walk-throughs, communication with personnel and training support
Other duties may be assigned as deemed appropriate by management
Qualification
Required
Four-year degree in Science or related field or approved equivalent experience in a cGMP environment
Has knowledge and understanding of cGMP & ICH Q7
Knowledge of relevant software applications including MS Office and Minitab
Knowledge of office systems and procedures
Knowledge of Supplier Approval Programs
Ability to communicate effectively with customers, regulatory agencies or member of the business community regarding inquiries or complaints
Organized, Thorough, Neat
Confidentiality
Lift up to 20 lbs. occasionally
Prolonged periods sitting at a desk and working on a computer Ability to see and distinguish color
Bend, stoop, and carry
Repeating motion that may include wrists, hands, and fingers
All BioSpectra job functions require the ability and willingness to work and travel to and from all locations in Pennsylvania, as needed in order to fulfill their job responsibilities
Employees who travel in excess of thirty miles in any workweek for business related purposes, will be reimbursed for their mileage, per standard federal mileage rates
This position requires internal education for continued growth and advancement
All employees are required to attend specific internal classes and training sessions deemed necessary for the position or requested by supervisors or senior management
BioSpectra requires this training to maintain and elevate your basic job skills and to remain appropriately trained in areas of Safety, Health and Quality Systems
Classes and training sessions missed must be made up on personal time at the convenience of the instructor
Benefits
Employees who travel in excess of thirty miles in any workweek for business related purposes, will be reimbursed for their mileage, per standard federal mileage rates.
Company
BioSpectra, Inc.
BioSpectra Inc.
Founded in 1994
201-500 employees
Funding
Current Stage
Growth StageRecent News
2023-08-09
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