JOB TITLE: QC Laboratory AnalystTechnician (Post-Sterile Lab)
DEPARTMENT: OperationsQuality
POSITION REPORTS TO: Microbiology Manager or Quality Manager
SALARIED: [ X ] HOURLY: [ ]
BASIC PURPOSE OF POSITIONSITION:
Technical QA/QC resource for the Post-Sterile laboratory. Provides laboratory support for post-sterile testing and associated microbiological and chemical quality control activities. Provides technical support for troubleshooting laboratory testing issues and non-routine analytical challenges.
ESSENTIAL FUNCTIONS/DUTIES:
- Perform routine laboratory testing in accordance with approved SOPs and test methods, including:
- Bioburden testing (membrane filtration method)
- Bacterial endotoxin testing (gel clot and kinetic methods)
- Total Organic Carbon (TOC) analysis (USP <643>)
- Conductivity and basic chemical testing (USP <645> and related methods)
- Particulate matter testing (USP <788>)
- Additional microbiological and chemical assays as required
- Ensure all testing is conducted in compliance with:
- USP, ISO standards (including ISO 13485 where applicable), and FDA requirements.
- Good Laboratory Practices (GLP) and internal quality system procedures.
- Accurately document all test results in laboratory notebooks, data management systems, and controlled forms in a timely manner.
- Execute laboratory validation and verification protocols as written, ensuring strict adherence to approved procedures, data integrity requirements, and regulatory standards.
- Perform routine equipment operation, calibration checks, and maintenance activities as assigned.
- Identify and escalate out-of-specification (OOS), atypical, or non-conforming results per procedure.
- Maintain laboratory cleanliness, aseptic technique, and compliance with contamination control practices.
- Support investigations, deviations, and corrective/preventive actions (CAPA) as needed.
- Assist with environmental monitoring activities and microbial identifications when required.
- Participate in internal audits and support external regulatory inspections as needed.
- Maintain organized and compliant laboratory records in accordance with GDP (Good Documentation Practices), ensuring compliance with data integrity principles.
- Support continuous improvement initiatives in laboratory efficiency, accuracy, and compliance.
KEY WORKING RELATIONSHIPS:
INTERNAL: Must be able to work as part of an interdisciplinary team interacting easily with the members of the team. Must be able to support the ongoing manufacturing of product. Must be able to provide technical consultation to other personnel in a positive, supportive way.
EXTERNAL: Must be able to work with outside vendors in support of product production. Must be able to interact with customers in solving customer problems.
SUPERVISORY RESPONSIBILITIES:
MINIMUM EDUCATION AND EXPERIENCE JOB REQUIREMENTS:
- Bachelor’s degree in Microbiology, Biology, Chemistry, or related life science.
- Quality Industry training courses.
- Minimum of 3 years of experience in a QC laboratory within a GMP-regulated industry (medical device or pharmaceutical preferred), including experience in microbiological and/or analytical testing.
- EAt least 3 years of experience with ISO13485 regulations and FDA, GMPand QSR requirements.
- Demonstrated ability to independently execute test methods with minimal supervision.
- Experience At least 3 years ofin SPCimplementation or routine data trending experience in a high- volume environment.
- Must be proficient in the use of office automation software including MS Word and Excel.
- JOB REQUIREMENT FACTOR RATINGS:
- H - High importance
- M - Medium importanceportance
- L - Low importance
Hearing H
Seeing H
Reading H
Speaking H
Balancing M
Walking M
Use of hands H
Use of arms H
Use of legs M
Lifting (max of 20 lbs.) M
Bending M
Standing M
Sitting H
Pay: $80,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Disability insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
