What are the responsibilities and job description for the Quality Control Technician position at Compunnel Inc.?
Title: Laboratory Technician / Quality Control Specialist
Key Responsibilities:
- Directly report to the Quality Site Lead and indirectly to the Laboratory Technician to ensure quality control laboratory testing, incoming quality control raw material inspection, and document control support duties are completed.
- Support the growth of a Fortune 500 subsidiary manufacturing serum and media products for life science and pharmaceutical applications.
- Comply with in-house and/or external specifications, standards such as cGMPs, 21 CFR 820, ISO 13485:2016, and Quality System Procedures.
Daily Activities:
- Perform in-process and finished product testing of applicable products, both in-house and through management of contract testing laboratories (endotoxin testing, Hemoglobin, water quality testing, and other laboratory test protocols).
- Assist with tracking and trending data related to products or systems such as facility water or cleanroom air quality.
- Conduct incoming QC inspection and release of raw materials upon receipt.
- Operate inside Class 1,000 and Class 100 cleanroom areas with understanding of aseptic technique.
- Assist with maintaining the product sample retention program.
- Drive critical dates of quality department deliverables and strive for on-time closure (i.e., release turnaround time, OOS investigations, nonconformances, CAPAs, etc.).
- Oversee controlled records management, including document control logging, scanning, and filing in a timely manner for easy access during audits.
- Review and revise procedures, specifications, and forms as needed.
Required Education:
- 4-year Biology Degree or Chemistry degree (bachelor's degree minimum required)
Required Experience:
- 1-3 years of experience in Manufacturing, Engineering, and/or Quality; specifically in a laboratory setting.
Required Skills:
- Ability to develop, update, and train on SOPs.
- Competent to learn prior knowledge of ISO standards and Quality Management Systems (QMS).
- Strong organizational skills; excellent time management skills.
- Good interpersonal and communication skills.
- Ability to follow detailed directions.
Desired Skills:
- Experience in a medical, pharmaceutical, or biotechnology environment preferred.
- Previous cell culture or microbiology laboratory experience preferred.
- SAP and/or PeopleSoft experience preferred.
- Knowledge of computer programs, such as Word, Excel, PowerPoint, etc.
