Overview
Quality Control Inspector Jobs in Lima, OH at Tuttle Services Inc
Job Scope/Description
The Quality Control Specialist is responsible for performing quality control testing of samples from islet cell manufacture. Quality Control Testing of islet cell product is performed under current Good Manufacturing Practice (cGMP) at CellTrans Inc. based at the University of Illinois Hospital & Health Sciences System. The individual reports to the Chief Quality Officer.
Responsibilities
Perform scientific laboratory duties as instructed in standard operating procedures (SOPs), following cGMP guidelines and aseptic technique.
Operate scientific instrumentation and specialized apparatus in accordance with defined guidelines.
Perform cell-based analytical assays for quality control testing of islet product, including but not limited to, glucose static incubation, ELISA, endotoxin, sterility and viability.
Participate in qualifications, process simulations, process validations, and method validations as required.
Generate quality control data in compliance with internal and external regulations.
On-call availability for Quality Control testing of islet cell product. Notification for the potential to be on-site for on-call duties will be provided a minimum of 12 hours in advance. Upon completion of the islet isolation, cell-based analytical assays (specified above) are required to be completed within 16 hours of the islet product being placed into culture for research. When the islet product is to be transplanted into a patient, completion of these assays needs to be performed as early as possible.
When Quality Control cell-based analytical assays are required to be conducted outside of regular business hours (8 am – 5 pm on weekdays) or during weekends, the extra hours worked will be categorized as “time off” hours to be taken at a later time.
Use good documentation practices to ensure compliance with regulatory and internal standards.
Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
Participate in lab inspections/audits and working collaboratively with inspectors/auditors as required.
Generate Quality Control data in compliance with internal and external regulations
Maintain sufficient inventory of supplies and reagents.
Perform raw material release for GMP use.
Support the supplier and service provider quality management program.
Support the execution of the training program.
Support investigation and review of manufacturing deviations, CAPAs, change controls and complaints.
Identify and implement continuous improvement efforts.
Collaborate with the Quality Unit to identify root causes and develop and implement Corrective Action Plans (CAPAs)
Work with personnel to resolve quality issues that arise as quickly and efficiently as possible to prevent compromising quality and safety standards.
Work with the Quality Control Unit to develop and validate quality processes by establishing product specifications and quality attributes; develop and determine operation and performance qualifications; write and update quality procedures.
Evaluate collected laboratory data and prepare reports with accuracy, completeness, and timeliness.
Prepare reagents and solutions necessary for experimental testing.
Assist in pharmacovigilance activities, including the monitoring, reporting, and evaluation of adverse events and ensuring compliance with regulatory requirements.
Utilize dexterity, knowledge, and skill to complete assigned laboratory tasks with attention to detail and in compliance with all applicable laboratory regulatory and safety requirements.
Perform other related duties incidental to the work described herein.
Requirements
Bachelor’s degree in biology, chemistry, microbiology, biochemistry or other related scientific or engineering fields.
Prior experience in procedures requiring aseptic technique and/or cell culture.
Proficiency with Microsoft Office programs (Word, PowerPoint, and Excel).
Effective oral and written communication skills.
Must be highly detail oriented.
Must have the ability to work in a cross-functional team environment.
Must be able to work a flexible schedule which may require weekend/holiday work and on-call work.
Must be able to work independently with minimal supervision.
This job description is representative of the types of duties and responsibilities that will be required of the position and should not be construed as a declaration of the sole duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Workers are prohibited from engaging in activities that impair their ability to perform job duties, such as alcohol or drug use.
Job Type: Full-time
Pay: $55,000.00 – $60,000.00 per year
Benefits:
Dental insurance
Health insurance
Paid time off
Retirement plan
Schedule:
8 hour shift
Work Location: In person
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Title: Quality Control Inspector
Company: Tuttle Services Inc
Location: Lima, OH
