Lab Technician
Department
Quality Control
Job Title
Lab Technician
FLSA Status
Non-Exempt
- Role Purpose:
- Key Duties & Responsibilities:
- Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
- Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
- Follow all DEA (Drug Enforcement Agency) regulations per laboratory SOPs.
- Keep Chemicals organized and in proper storage areas.
- Receive Chemicals and Laboratory materials and keep log.
- Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques in compliance with written, approved methods.
- Document all performed analysis as per cGMP, USFDA and 21CFR211.194 guidelines. Maintain laboratory records including notebooks, logs, and other pertinent documentation in compliance with cGMP, SOPs, and good laboratory documentation guidelines.
- Ensure all instruments are qualified, and calibrated before each use.
- Ensure all instruments are maintained, cleaned and used appropriately.
- Place chemical and solvent orders
- Follow all SOPs.
- Comply with FDA guidelines/Company Policies of Data Integrity
- Other duties as assigned or delegated
- Typical Supervisory Responsibility:
- Education & Experience:
Experience Requirement
- Technical competencies/ Certifications/ Licenses:
- Working knowledge of HPLC, UPLC, GC Dissolution, AA, or UV spectrophotometers preferred
- Good verbal and written English
- Physical demand and Work environment:
- Physical demands:
- Work environment:
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Pharmaceutical Manufacturing
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