Job Summary

The primary responsibility of this position is to complete daily Microbiological, Analytical and Sensory testing of environmental samples, finished products and intermediate materials to meet necessary release criteria. This role is to serve as a key member of Microbial Daily Management program, including daily sampling of converting lines and ancillary equipment. Role has a complete understanding of the Quality System and assist in the implementation of any new systems or validations as required. Position is responsible for incoming material identification testing of raw or intermediate materials. Position takes daily direction from Quality Control Laboratory Lead but reports to the Quality Control Manager.

Essential Functions:

• Understand and perform work in accordance with the Quality Management System
• Perform daily activities of the Micro, Analytical and Odor labs; including but not limited to:
  1. Aseptically processing Raw, Intermediate, and Finished Products samples for applicable microbial tests
  2. Reading microbial test results and performing selective or differential tests as needed
  3. Completing data reviews and release of formulations for production
  4. Maintain laboratory inventory of supplies and reporting needs to Laboratory Lead
  5. Troubleshooting, maintaining and calibrating equipment, such as:
     • pH meter – pH levels
     • FTIR – Identification of raw materials for release
     • UV/VIS spectrophotometer- Identification and quantification
     • HPLC - Quantitation of active ingredients, preservatives, etc.
     • All new equipment as required by project
• Assist in the training and qualification of new Quality Control Technicians
• Leading investigations of corrective actions or out of specification results
• Assisting in validation efforts and system improvement or reviews
• Use and understand quality software to interpret run charts and ensure test result accuracy, communicating results to Quality Control Manager or Laboratory Lead to ensure minimal process variation
• Follow Good Laboratory Practices as appropriate and document all work in accordance with standard operating procedures
• Proper handling and disposal of chemicals and understanding the HMIS codes
• Perform problem-solving functions when called upon.

Minimum Qualifications:

• Associate Degree in Microbiology, Biology or related science degree
• Working knowledge of FDA/cGMP/GLP

Preferred Qualifications:

• Bachelor’s Degree in Microbiology, Biology or related science degree
• Previous laboratory experience in a Micro Related Atmosphere

Work Requirements:

• Works in a safe and ethical manner at all times
• Strong organizational skills and ability to multitask and reprioritize work as needed
• Ability to work independently and as a team
• Strong interpersonal, verbal and written communication skills
• Ability to work a flexible schedule, including nights and weekends
• Strong judgment/decision making skills
• Ability to follow written SOPs
• Strong ethical standards and safety conscious
• Strong aseptic technique and analytical skills
• Provides leadership to peers and team members as needed
• Train-the-Trainer certified
• Completion of cGMP for Supervision
• Strong focus on quality and safety
• Quality Control Laboratory Technician Qualification
• Must possess a positive attitude, willingness to learn and have good attendance

Disclaimer:

The above statements are intended to describe the general details of the essential responsibilities being performed in the job. It is not designed to be a comprehensive list of all duties and responsibilities. All associates may be required to perform duties outside their normal responsibilities from time to time, as needed. The company reserves the right to make changes to the job description at any time.