QA Technician I, Majestic

Biospectra Inc•Bangor, PA

5d•Onsite

About The Position

The QA Technician I, Majestic performs quality assurance functions specific to material disposition to ensure continuous production in accordance with established procedures, guidelines and standards at the Bangor, PA facility. This position will be responsible for the execution of Quality Assurance activity including but not limited to the review and disposition of raw materials, components, and finished goods while ensuring good manufacturing practices are followed throughout the facility.

Requirements

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.

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.