Job Description

POSITION / JOB SUMMARY:

This position reports to Quality Assurance Manager. The QC Lab Technician role will support process and product quality testing by preparing equipment and materials, recording and analyzing results gathered during product development and production.

This position is responsible for submitting samples such as TOC Device Extraction, pH test, Water collection for Bioburden, air particulate testing. Position also has documentation responsibilities.

Position Responsibilities / Essential Functions:

Primary responsibilities:

· Collect, prep, and submit samples to various labs.

· Verify and analyze results.

· Prep/Mix chemical formulation for Production/Manufacturing use.

· In-process quality control tasks.

· Maintain maintenance records for all Equipment.

· Perform Environmental Monitoring of Cleanroom.

· Perform daily Pre-Operational QC checks of Passivation Chemistry.

· Perform package Visual Inspection, Seal Strength, and Integrity Testing.

· Perform analytical tests using an FTIR, Microscopes, Smart Desiccator, and an Ultraviolet-visible spectroscopy.

· Other Laboratory tasks as required.

QC Tasks

This position has secondary responsibility of performing receiving inspection, label inspection, in-process and final inspection functions including:

· Inspect medical device components.

· Ability to use measurement equipment such as Micrometer, Calipers, and Rulers.

· Review sterilization certificate for full release.

· Review the LHR's for completion.

· Capable of maintaining accurate records.

· Other QC tasks as required.

Required Qualifications:

Education:

· Associates degree required, bachelor's degree preferred (Science-field preferred)

Experience / Qualifications:

· General familiarity with analytical lab equipment such as FTIR, HPLC, Air particle analyzer.

· Experience working in a sterile environment.

· Must be capable of reading and interpreting technical drawings.

· Must have knowledge of MS Excel and MS Word

· Must be detail-oriented with a high level of accuracy and have good interpersonal skills.

· Must be able to understand and follow written/verbal instructions.

· Must have time management and prioritization skills.

· Ability to perform simple math including addition, subtraction, multiplication, division, and percentages.

· Medical device and GMP/GDP experience preferred.

Note: Reasonable accommodations may be made for individuals with disabilities.

Language Skills:

· Ability to read, analyze, and interpret written instructions and procedures in the English language.

Reasoning Ability

· Ability to interpret a variety of instructions furnished in written, oral, or diagram form.

· Ability to understand manufacturing specifications and procedures.

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