Lead Scientist

Fresenius Kabi • Wilson, NC

1d

About The Position

A Lead Scientist in Quality Control Chemistry has broad expertise in routine as well as complex chemical methods of analysis. The incumbent is typically assigned the more complex test methods due to his or her advanced training in specialized methods of analysis. In addition, the Lead Scientist is responsible for assisting the Quality Control Supervisor in ensuring the laboratory successfully operates in compliance with cGMP and other laboratory regulations. Oversees and organizes the training and development of less experienced analysts in the group.

Requirements

• Broad expertise in routine as well as complex chemical methods of analysis
• Advanced training in specialized methods of analysis
• Assisting the Quality Control Supervisor in ensuring the laboratory successfully operates in compliance with cGMP and other laboratory regulations
• Oversees and organizes the training and development of less experienced analysts in the group
• Expertise in high level testing utilizing instrumental methods of analysis (HPLC, GC, TLC, AA, ICP-MS, KF) with emphasis on chromatography
• Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, and Deviations.
• Expertise in documentation requirements of the department as well as cGMP, GDP/GLP practices.
• Ability to update and improve training modules for new analytical techniques used within the Quality Control laboratory.
• Ability to train analysts on newly implemented laboratory techniques as a Qualified Trainer and/or mentor.
• Ability to provide technical expertise and leadership where necessary.
• Ability to make recommendations for future courses of action using independent judgement and reasoning.
• Ability to summarize findings from evaluations, investigations, protocols, in a clear, concise manner.
• Ability to perform peer review of data to ensure compliance and accuracy.
• Ability to perform technical review of documentation, procedures, reports, etc.
• Ability to learn comprehensively about a new subject (i.e. new instrumentation, methodology, technique) and communicate it to less experienced personnel.

Nice To Haves

• Networking with other FK sites and departments to help coordinate projects and ensure compliance when needed.

Responsibilities

• Be able to articulate work related issues clearly and effectively to management and peers
• Performs and demonstrates expertise in high level testing utilizing instrumental methods of analysis (HPLC, GC, TLC, AA, ICP-MS, KF) with emphasis on chromatography to meet departmental objectives.
• Networks with other FK sites and departments to help coordinate projects and ensure compliance when needed.
• Independently authors and directs investigative studies (required for OOS or OOT results), deviations, and other necessary documents for the Quality Control department.
• Advanced working knowledge of KabiTrack and recording Investigations such as OOS, OOT, and Deviations.
• Displays expertise in documentation requirements of the department as well as cGMP, GDP/GLP practices.
• Updates and improves training modules for new analytical techniques used within the Quality Control laboratory.
• Trains analysts on newly implemented laboratory techniques as a Qualified Trainer and/or mentor.
• Provides technical expertise and leadership where necessary.
• Makes recommendations for future courses of action using independent judgement and reasoning.
• Able to summarize findings from evaluations, investigations, protocols, in a clear, concise manner.
• Performs peer review of data to ensure compliance and accuracy.
• Performs technical review of documentation, procedures, reports, etc.
• Ready and able to learn comprehensively about a new subject (i.e. new instrumentation, methodology, technique) and communicate it to less experienced personnel.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• 401K with company contribution
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed