Associate Scientist

Work Schedule

10 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Position Summary: The Quality Control Scientist is responsible for the growth promotion and physical quality control aspects of finished product testing. This role ensures that the performance of finished products aligns with testing standards per Instructions For Use (IFU), Standard Operating Procedures (SOPs), customer requirements, and regulatory guidelines. The role also includes documentation control duties per Quality Assurance compliance requirements.

Key Responsibilities:

• Review and maintain product compliance specifications and documentation control.
• Gain proficiency in all performance testing of core growth promotion and inoculation of AST products.
• Complete Out of Specification (OOS) reports and assist with investigations.
• Document testing results and determine product disposition.
• Maintain consistency in training within Master Control.
• Establish and maintain SOP criteria for inspection and testing.
• Maintain department equipment and request consumables as needed.
• Exercise and monitor Good Manufacturing Practice (GMP) compliance in the work environment.
• Collaborate closely with the Quality Assurance department as part of the quality team.
• Complete Stability Study testing in accordance with Quality Assurance requirements.
• Work with Customer Service Representatives to achieve on-time product releases for standing orders and special products.
• Participate in continuous improvement programs within the department.
• Collaborate closely with a team in a fast-paced laboratory setting.
• Understand and adhere to all safety requirements and procedures.
• Assist in maintaining standards in accordance with GMPs, SOPs, and ISO regulations.
• Participate in achieving department goals.
• Support all company policies.
• Perform other duties as assigned.
  
  

Minimum Requirements/Qualifications:

• A 4-year degree in biological sciences, with coursework in microbiology with a laboratory, or a non-science related 4-year degree with 3-4 years of microbiology lab experience.
• A minimum of 1-2 years of combined experience in related Quality Control/Quality Assurance, microbiology laboratory work, or an equivalent combination of education and experience.
• Proficiency in basic laboratory skills and techniques (pipetting, swabbing, streaking, pouring plates, etc.).
• Familiarity with FDA regulations for medical devices.
• Ability to manage multiple tasks in an organized manner.
• Effective communication skills with various departments regarding quality testing parameters.
• Intermediate computer skills, with experience in Microsoft Word, Excel, and PowerPoint; experience with SAP is a plus.
• Ability to listen to and follow written and verbal instructions.
• Adaptability to learn new procedures and maintain a scientific and objective approach.
• Availability to work weekend shifts as needed.
• Self-motivated, highly responsible, and possess a good teamwork spirit.
• Excellent verbal and written communication skills in English.
  
  

Non-Negotiable Hiring Criteria:

• Candidate must be a good time manager.
• Candidate must be willing to put in overtime when needed to complete tasks.
• Candidate must be a good team player/participant on teams.
• Candidate must have a high sense of responsibility.
• Candidate must possess critical thinking skills.