Posted 19h ago

QA Technician I, McConnell

@ BioSpectra
Stroudsburg, Pennsylvania, United States
OnsiteFull Time
Responsibilities:inspecting materials, issuing coas, performing audits
Requirements Summary:Entry-level QA role supporting incoming material inspection, finished goods inspection, COA creation, labeling, facility audits, documentation practices, and discrepancy investigations; bachelor's in science preferred.
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Job Description

Quality Assurance Technician


If you are attracted to a career opportunity with a growing chemical manufacturer and a major supplier of chemical ingredients to the bio-pharmaceutical industry, this may be the job for you!


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. 

 

Major Roles & Responsibilities:

The ideal candidate will be able to perform the following responsibilities.

  • Incoming Process Material Disposition: Supports the inspection, proper disposition and documentation for incoming materials and components. 
  • Finished Goods Inspection: Supports and performs finished goods inspection and Quality Assurance approval prior to final shipment of finished goods.
  • Certificate of Analysis: Creates and issues Certificate of Analysis (COA) documents.
  • Labelling: Assists in labelling and issuing of labels in inventory and outgoing shipments.
  • Facility Audits: Performs daily audits of the facility to ensure BioSpectra procedures and policies are being followed.
  • Good Documentation Practices: 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.
  • Quality Assurance Management: Identifies and reports process or system deviations to QA Management. Performs Discrepancy Investigations and provides an investigation report to QA Management.

 

Qualifications:

The ideal candidate will be a recent graduate or will graduate soon with the following education, background.

  • The ideal candidate will have 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.


In addition, the ideal candidate will have the following qualities which will be critical to their success in this role.

  • Detail Orientation: 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.
  • Effective Communication: 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. 
  • Organizational Aptitude: Ability to plan and organize their work and information in a structured and logical way.
  • Investigative Mindset and Critical Thinking: 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.
  • Capability of Learning: An ability to understand and assimilate knowledge and understanding of cGMP, ICH Q7 regulations, supplier approval programs and BioSpectra policies and procedures.
  • Software Technology: Ability to use software technology and systems, to assist the Compliance Department as needed.


If you believe you have the right background and qualities and want to build a career with a growing organization, please reach out to us!