QC Microbiologist

Summary

The Quality Microbial Control Analyst I / QC Microbiologist will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots and quality testing for ongoing customer stability studies. The role provides on-time, high-quality results to meet manufacturing demands and applies job skills, policies, and procedures to complete a variety of tasks. The position is entry-level and involves semi-routine assignments requiring the ability to recognize deviations from accepted practices and work on problems of moderate scope.

Responsibilities

• Run test samples for In-Process, Lot Release, and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility.
• Use Microsoft Word, Excel, and PowerPoint.
• Use laboratory computer systems.
• Apply Data Integrity principles in all aspects of work in compliance with applicable policies, guidelines, and procedures.
• Apply job skills, policies, and procedures to complete assigned tasks.
• Recognize deviations from accepted practices and determine appropriate action within defined procedures and practices.
• Complete assignments accurately and on time.
• Work effectively as an active member of the team.
• Maintain commitment to quality and perform job functions to the best of one's ability.
• Adhere to cGMPs at all times during the manufacture of APIs.
• Take responsibility for the quality of work delivered and promptly notify management of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.
• Follow job safety procedures and attend required health and safety training.
• Proactively promote workplace safety and promptly report actual and potential accidents and injuries.
• Comply with site and company safety policies.
• Work the entire assigned shift, including arriving on time.
• Perform other duties as assigned.

Required Skills

• High School Diploma or equivalent required.
• Associate's Degree preferred, preferably in Microbiology, Biochemistry, or a related science field.
• Entry-level Quality Control/Laboratory experience: 0–4 years.
• Strong ability to interpret data independently and with guidance.
• Ability to perform assigned complex and/or varied tasks.
• Prioritization and problem-solving skills.
• Ability to comprehend and follow instructions.
• Strong written and verbal communication skills.
• Ability to exercise judgment within defined procedures and practices to determine appropriate action.
• Ability and desire to learn from experience.
• Ability to treat errors as learning opportunities.
• Ability to work effectively as a self-motivated team player.
• Ability to relate to others in a team setting.
• Ability to complete assignments accurately and on time.
• Commitment to quality.
• Ability to understand internal and/or external customer needs.
• Ability to monitor KPIs with the supervisor and consistently deliver goals.
• Ability to take responsibility for personal and team safety.
• Knowledge and adherence to cGMP requirements.
• Understanding and application of Data Integrity principles.

Pay

$25 to $35 per hour – Negotiable depending on experience.