QA Technician I
10 Southgate Rd Scarborough, ME 04074 US
The position of Quality Assurance Technician I is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will under basic direction and supervision, 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.
- Conduct product testing, to support complaint investigations and stability verification
- Generate product testing results reports
- Assist with 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 assure these have been addressed and resolved prior to issuing approval.
- Initiate Quality Incidents (QI)
- Conduct spot-check inspections/audits of production operations
- Write Standard Operating Procedures (SOPs) as necessary
- May assist in supporting the Document Control program, record retention areas, and sample retention areas
- Assist in the management of the Calibration program
- Assist in the management of the Stability Program
- Assist in the management of the Retention Program
- Communicate quality issues to QA Management in a timely manner
- May support returned instrument processing
- 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.
- Other duties as assigned
BASIC QUALIFICATIONS | EDUCATION:
- Bachelor' s Degree in Biology, Chemistry, Life Science, or related technical field or the equivalent combination of experience and education.
- 1+ years in quality assurance role in medical device industry
- Prior experience using the following:
- pH meters
- Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
- Working knowledge of Spreadsheet and Word Processing software
- Ability to follow procedures and accurately document results
- Ability to understand the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
- Attention to detail
- Ability to use bleach for cleaning purposes is required
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.