QA Technician I

Quality Assurance Technician I

Position Summary:

The Quality Assurance Technician I at BioSpectra is an ideal position for an individual with a Science degree, who either just recently graduated or has one to two years of experience, ideally with a life science company and loves the idea of ensuring BioSpectra continues to meet its high-quality standards.

This position performs functions specific to material disposition to ensure continuous production of pharmaceutical ingredients. This position is responsible for the review and disposition of raw materials, components and finished goods in accordance established procedures and good manufacturing practices.

Major Roles & Responsibilities:

Documentation Issuance & Review:

Issues analytical summary sheets for all products manufactured or packaged at BioSpectra’s Majestic, PA facility.

Issues Batch Records including all documentation for accountability of labels, seals, lot number assignment associated with the release of the manufactured product.

Ensures Quality records are accurate, approved and in compliance with cGMP standards.

Finished Goods Review & Disposition:

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.

Performs Finished Good Inspection/QA Approval prior to Finished Good Shipments at BioSpectra’s Bangor, PA facility.

Raw Material & Component Review and Disposition:

Inspects incoming Components and Raw Materials.

Disposition and Monitoring of Regulated Inventory

Approves and monitors the usage of regulated inventory in Sage ERP system.

Corrective and Preventative Action & Handling Non-Conforming Events:

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.

Other Quality Documentation Reviews:

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.

Quality Audits

Ensures that the facility is functioning in accordance with established quality policies and procedures through document review and approval, quality walkthroughs, communication with personnel and training support.

Optimize Quality Results

Recommends modifications of existing quality or production standards to achieve optimum quality within limits of manufacturing capability.

Qualifications:

Education:

Bachelor’s degree in Science or related field and/or equivalent experience with a life-science or cGMP organization.

Experience:

The preferred candidate will two years’ experience in a quality assurance position, with a life science company or manufacturer, with a working knowledge of cGMP or ICH Q7 requirements. However, BioSpectra will consider a recent college graduate with the right attributes.

Skills & Abilities: The ideal candidate will have the following skills and abilities.

Organizational – Ability to organize and maintain data and information in a structured organized manner

Detail Orientation – Ability to pay attention to details and ensure that information being relayed is through and accurate.

Decision-making –  Ability to gather all pertinent data and information to make competent, timely, informed decisions with regard to changing priorities.

Communication: Must be able to communicate effectively to individuals at all levels of the organization and be able to coordinate actions to achieve an objective. Must be able to communicate effectively with customers, regulatory agencies and other outside parties.

Computer Skills – Must possess intermediate to Advances skills with Microsoft Office software, including Outlook Calendar. Have familiarity with the use of Minitab or similar statistical software.

Supplier Approval Programs – Must have or demonstrate their ability to acquire knowledge of supplier approval programs.