We are seeking a Quality Control Technician for a very important client.

Pay - $38.00 to $41.50

Shift - 9pm to 7:30am Sunday to Wednesday

Location - Scarborough, ME

Job Duties -

• Perform a wide variety of activities to support the Quality Management System.
• Conduct product testing, including testing to support complaint investigations and stability verification
• Generate product testing results reports
• 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.
• Conduct spot-check inspections/audits of production operations
• Participate in the internal audit program
• Write, review and approve Standard Operating Procedures (SOPs) as necessary
• May assist in supporting the Document Control program, record retention areas, and sample retention areas
• 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.

The ideal candidate will possess the following qualifications:

• Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)
• Education and/or Experience Bachelor's degree in a scientific or technical area or equivalent combination of experience and education.
• At least one year in quality assurance role in medical device industry is preferred.
• Language Skills Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before small groups of customers or employees of organization.
• Mathematical Skills Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Computer Skills To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.

Job Types: Full-time, Contract

Pay: $38.00 - $41.50 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Night shift

Ability to commute/relocate:

• Scarborough, ME: Reliably commute or planning to relocate before starting work (Required)

Experience:

• QA: 3 years (Required)
• Review Batch Records: 3 years (Required)

Shift availability:

• Overnight Shift (Required)

Work Location: One location

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