- Perform all work in compliance with company policy and within the guidelines of its Quality System.
- Responsible for performing quality control testing on incoming reagents used in Film Array.
- Responsible for maintaining supplies and inventory counts.
- Responsible for coordinating instrument/equipment repairs as necessary.
- Provide support if needed in other projects or validations from various departments within the company.
- Responsible for learning new techniques or workflows as required for new product lines.
- Responsible for all instrument CAL/PMs, pipette calibrations, Artel system calibration, UV hood bulbs, etc.
- Responsible for all Film Array Contamination monitoring, collection, setup and reporting.
- Responsible for all other swab set up and reporting.
- Responsible for QC data entry.
- Responsible for maintaining the QC area clean and contamination-free.
- Responsible for coordinating repeat testing.
- Works closely with QC Manager, Instrument Production leads, Service Center leads, and Reagent QC to ensure consistent and timely turnaround for QC results.
- Responsible for maintaining records as required by the Quality System.
- Responsible for data review, reporting, and component release.
- Responsible for responding to inquiries and reviewing corrections.
- Responsible for product release in Production Web.
- Generates Non Conformance Reports.
- Reports daily metrics to management.
- Performs troubleshooting as needed.
- Performs other duties as assigned.
- This is an entry-level position within the company
- Must work assigned shift and have ability to work flexible schedule
- Must work mandatory overtime as assigned
- Must work full time hours as defined by the department
Training and Education:
- Associate Degree in life science or related field is required. A Bachelor’s of Science in a life science or engineering related field is strongly preferred.
- 6 months experience in a laboratory/engineering setting is required.
- Any experience in Quality Assurance or Quality Control is preferred and previous cGMP experience is strongly preferred.
Skills and Qualifications:
- Ability to accurately follow both written and verbal instructions
- Demonstrated proficiency with Microsoft Office Suite (Outlook, Word, and Excel)
- Highly collaborative and team oriented
- Highly organized and motivated
- Effective communication skills, both written and verbal
- Very high attention to detail
- Demonstrated proper pipetting technique
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
- Must be able to lift at least 25 lbs.
- Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.
- Must be able to perform repetitive tasks with hands for a moderate amount of time.