Quality Lab Technician
Ormond Beach, FL, US
Position Summary
This position reports directly to the QC Supervisor and is primarily responsible for performing analytical testing, laboratory investigations and analytical method transfers for an OTC drug manufacturing facility. This position is also responsible for any other additional tasks assigned by the QC Supervisor.
Universal Accountabilities
• Performs raw material, in-process and release testing using a variety of analytical techniques (UV-Vis, IR, HPLC, GC, AA, titrations, viscosity analysis, etc.).
• Follows cGMP, USP and 21CFR 210/211 requirements for laboratory testing and OOS investigations.
Specific Accountabilities
• Technical knowledge of chromatography and bench chemistry.
• Review notebooks, forms, and raw data.
• Good computer skills. Proficiency with Word and Excel. LIMS experience a plus.
• Ability to apply basic statistics and compare data trends.
• Effective verbal / written communication, interpersonal, and team-building skills.
• Excellent organizational, problem-solving, prioritizing and follow-up skills.
• Ability to handle multiple tasks / projects simultaneously.
Required Skills and Experience
• BA or BS preferable in Biology, Chemistry, Engineering, Microbiology or related field
• Working knowledge of cGMPs as applicable to laboratory environment.
• Excellent communication skills, written and verbal
• Problem solving skills, including root cause analysis
• Knowledge of basic statistics
• Must be able to read, write, and understand English.
• Must be able to follow verbal and written instructions
• Ability to verify numbers, words and alphanumeric combinations across multiple mediums
• Must be open to occasional off shift and weekend hours
• Ability to apply basic statistics and compare data trends.
• Effective verbal / written communication, interpersonal, and team-building skills.
• Excellent organizational, problem-solving, prioritizing and follow-up skills.
Preferred Skills and Experience
• SAP, Microsoft Excel, Word, Access, Agile and SharePoint experience, preferred
• Ability to maintain a high level of confidentiality
• Must be detail oriented
• Good interpersonal skills
• Strong organizational skills
• Ability to work in a dynamic environment and be self-motivated
• Ability to change directions, remain flexible and respond quickly
• Minimum of 1-year hands-on experience supporting cGMP manufacturing environment.
• Minimum of 1-year hands-on experience in lab
Working Relationships
• Reports to QC Supervisor but must work in close proximity to QC Lab Technicians and QC Chemists.
• Ability to walk and stand for long periods of time
• Ability to work long periods on repetitive tasks effectively
• Comfortable in a production environment
• Ability to lift approximately 50 pounds