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QA Technician II

Scarborough, ME 04074

Posted: 09/12/2022 Employment Type: Contract Job Number: 514892 Country: United States Is job remote?: No

Job Description


The position of Quality Assurance Technician II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will under minimal direction, perform a wide variety of activities to support the Quality Management System.
This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:
? Conduct product testing to support complaint investigations and stability verification
  • Generate, document and asses product testing results
  • Perform troubleshooting activities

? Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
? Collaborate with Manufacturing and QC groups to resolve issues in quality records
? Initiate and author Quality Incidents (QI)
? Participate in the internal audit program
? Conduct spot-check inspections/audits of production operations
? Write, review and approve Standard Operating Procedures (SOPs) as necessary
? Manage or assist in the management of the Calibration program
? Assist in supporting the Document Control program, record retention areas, and sample
retention areas
? Communicate quality issues to QA Management in a timely manner
? Train new and current Quality Assurance technicians as needed
? Manage or assist in the management of the Stability Program
? Manage or assist in the management of the Retention Program
? Other duties as assigned
? May support returned instrument processing which includes:
  • Log returned instruments from the field.
  • Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
  • Inspect returned instruments for damage and performing basic investigation and documenting results prior to second level processing.
  • As necessary, process instrument documentation for return to repair facility, and pack instruments as required.

BASIC QUALIFICATIONS | EDUCATION:
? Bachelor's Degree in Biology, Chemistry, Life Science, or related technical field or the equivalent combination of experience and education.
? 3+ years in a Quality Assurance role within the medical device industry.

COMPETENCIES:
? Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
? Ability to perform Immunological Assays and NEAR Molecular assays
? Knowledge of site software for inventory management, Document Control, Quality incident tracking and Customer Complaint tracking
? Good working knowledge of Excel and Microsoft Word software.
? Ability to follow procedures and accurately document results
? Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
? Ability to speak effectively before small groups of customers or employees of
organization.
? Ability to use bleach for cleaning purposes is required
? Attention to detail
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