Job Information
Astrix Technology QA Specialist in Ashtabula, Ohio
QA Specialist
Quality Assurance
Ashtabula, OH, US
- Added - 25/06/2024
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Quality Assurance Specialist
Our client is aleadingglobal chemical group in Ashtabula, OH.They are looking for a QA Specialist to join their growing team!
Annual Salary – up to $75k
Hours: 8:00 am – 4:30 pm, Monday through Friday
Type: Hybrid (3 days in/2 days out of the office)
Responsibilities:
The generation, review, facilitation of corrections, and archival of documents used to supportGood Manufacturing Practice manufacture of Final Product.
Perform internal and external audits as assigned.
Review and release raw materials, intermediate products and finished products. Assist incoming material and tote inspection.
Perform review and approval of OOS, deviations, nonconformance, and investigation asrequired.
Coordinate CAPA, OOS, deviations, nonconformance, and investigations
Ensure systems comply with current SOPs.
Assist investigations and resolve potential product quality issues to improve efficiency.
Assist with writing, revising, and approving standard operating procedures and workinstructions.
Review and approve SOP, protocols and reports as necessary.
Coordinate and/or conduct GMP training and SOP training.
Generate, publish, and manage quality systems metrics to drive continuous improvement.
Scanning/archiving of GMP documents.
Assist QC Lab Manager with QMS related functions including calibration, release, etc.
Requirements
Bachelors’ degree in a scientific discipline or equivalent experience.
2 years’ experience in cGMP/FDA environment (preferred) and ISO 9001 within relevant
Training experience a plus.
Experience with QT9 a plus.
Strong background in ISO 9001-2015, ISO 14001-2015, cGMP, CFR 210/211, FDA, Pharmaceutical, HACCP, Food Safety Management and ICHQ7 requirements.
Experience in a manufacturing environment, with a strong preference towards chemicalmanufacturing/processing.
Knowledge of statistical process control (SPC) and applicable software.
Knowledgeable indetermining cost of quality using data driven key indicators.
Strong project, time management and conflict resolution skills.
Exceptional written and verbal communication skills.
Able to speak professionally and report on all Quality related issues for all assigned sites with confidence.
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.