QA Technician I, McConnell

Biospectra Inc•Stroudsburg, PA

41d

About The Position

The Quality Assurance Technician l, McConnell performs quality assurance functions specific to material disposition to ensure continuous production in accordance with established procedures, guidelines and standards at the McConnell facility. This position is directly responsible for the QA oversight involving but not limited to the inspection and approval of materials and components, supporting the review of controlled documentation and ensuring good manufacturing practices are followed throughout the facility.

Requirements

A Four-year degree in Science or related field or approved equivalent experience in a cGMP environment is required.

Nice To Haves

Demonstrated working knowledge and understanding of cGMP & ICH Q7.
Knowledge of relevant software applications including MS Office.
Knowledge of office systems and procedures.
Ability to communicate effectively to all levels of the organization.
Can demonstrate they are neat, organized and can plan and execute tasks effectively.
Can demonstrate they are accurate and thorough in the quality of their work.
Can maintain a high degree of Confidentiality.

Responsibilities

Prints, issues and reconciles BioSpectra labels and seals for Finished Goods Packaging.
Performs Finished Good Inspections and/or QA Approval prior to Finished Good Shipments.
Performs Finished Good Inspection Final Review upon completion of Finished Good Shipments.
Inspects, reviews and assigns disposition for incoming components and raw materials.
Approves and monitors the usage of regulated inventory in the electronic inventory system.
Supports and implements temporary operating instructions to be issued for quality activities.
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 procedure through document review and approval, quality walkthroughs, communication with personnel and training support.
Performs quality review of facility documentation including logbooks.
Reviews, evaluates and approves the pest control logbook and assessments.
Reviews and approves Maintenance work orders and preventative maintenance documentation.
Notifies management of any non-confirming events and assists with writing or reviewing investigations.
Communicates any quality related requirements or findings to applicable department staff to ensure the correction or prevention of non-conforming events.
Scanning and filing quality documents.
Other duties may be assigned as deemed appropriate by management.