QA Technician I, McConnell

Biospectra Inc • Stroudsburg, PA

5d

About The Position

BioSpectra is seeking a QA Technician to support documentation of receipt of process materials, inspection of incoming materials and finished goods prior to release. This is an entry level position and a career opportunity for someone who has recently graduated from college or university or plans to graduate soon.

Requirements

• A four-year degree in Science or other closely related field with a strong interest in a career in the life sciences promoting quality assurance.
• Demonstrated ability to inspect and investigate details with the objective of determining that materials and processes are in compliance with BioSpectra’s policies and procedures. This ideal individual must be both accurate and thorough in the execution of their work.
• Demonstrated ability to communicate effectively, both verbally and in writing, to individuals and departments within BioSpectra as well as customers, regulatory agencies, and other interested parties.
• Ability to plan and organize their work and information in a structured and logical way.
• Possess an “investigative mindset” that ensures that inspections, audits, and work is thorough and accurate and the ability to are assess a situation and act decisively and effectively based on this assessment.
• An ability to understand and assimilate knowledge and understanding of cGMP, ICH Q7 regulations, supplier approval programs and BioSpectra policies and procedures.
• Ability to use software technology and systems, to assist the Compliance Department as needed.

Responsibilities

• Supports the inspection, proper disposition and documentation for incoming materials and components.
• Supports and performs finished goods inspection and Quality Assurance approval prior to final shipment of finished goods.
• Creates and issues Certificate of Analysis (COA) documents.
• Assists in labelling and issuing of labels in inventory and outgoing shipments.
• Performs daily audits of the facility to ensure BioSpectra procedures and policies are being followed.
• Ensures that Good Documentation Practices are followed on all submitted documentation and log books. Identifies documentation errors and concerns and immediately communicates the requirements for correction to the specific employees involved.
• Identifies and reports process or system deviations to QA Management. Performs Discrepancy Investigations and provides an investigation report to QA Management.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level