Microbiologist I

Avara Pharmaceutical Services; Norman (OK); On-site; USD 44,000 - 62,000; Full time

Job summary

Avara Pharmaceutical Services is seeking a microbiology specialist to support its pharmaceutical manufacturing operations. You will perform and review microbiological testing on materials and products, ensuring compliance with cGMP and QA standards, and monitor environmental conditions across the facility.

The role requires at least two years in a microbiology lab, a BS degree in microbiology or related science, and strong problem-solving and time-management skills.

Qualifications

• Must have at least two years of experience in a microbiology laboratory.
• BS degree in microbiology or other science-related field.
• Thorough knowledge of cGMP and Quality Assurance requirements.
• Knowledge of arithmetic, algebra, geometry, calculus, statistics and their applications.
• Must read, write and understand English.
• Must be able to identify complex problems and implement solutions; strong time management and multi-tasking skills.
• Ability to operate laboratory equipment safely (e.g., autoclaves, Vitek system) and read instructions.

Responsibilities

• Perform microbiological testing on raw materials, in-process and finished goods per USP, JP, JPE, EP and non-compendia methods.
• Sample, monitor and trend environmental testing and pest control activities.
• Document results according to cGMP and review testing to support manufacturing.
• Perform Out of Specification (OOS) investigations and implement CAPA.
• Prepare protocols, summaries and reports for sanitation testing, validation, routine monitoring, SOPs and IQ/OQ/PQs.
• Perform validations, calibrations and preventive maintenance on laboratory equipment.

Skills

Microbiology lab

cGMP knowledge

Quality Assurance understanding

Mathematics knowledge

English proficiency

Problem solving & multi-tasking

Time management

Laboratory equipment operation

Education

BS in microbiology or related science

Tools

Vitek system

Autoclaves

Job description

Provide necessary support to the facility by performing and reviewing microbiological testing on all items associated with a pharmaceutical manufacturing facility.

• Perform raw material, in-process and finished goods micro testing according to both compendia (USP, JP, JPE, and EP) and non-compendia test methods while adhering to cGMP requirements for pharmaceutical products.
• Sample, perform, monitor, and trend all environmental testing associated with the facility. Monitor and trend pest control activities at the facility.
• Document according to cGMP requirements and review all testing in a timely manner to support the manufacturing facility.
• Perform Out of Specification (OOS) investigations and determine the appropriate CAPA (Corrective Action/Preventive Action).
• Prepare protocols, summaries, and reports related to sanitation testing, validation, routine monitoring, SOPs, and IQ/OQ/PQs.
• Perform validations, calibrations, and preventive maintenance on all equipment within the micro laboratory.

Quantitative Dimensions:

• Work cross-functionally with local teams, directly impacting APT’s commercial products

Organizational Context:

• Reports to Manager of Quality Control

Qualifications:

Required

• Must have at least two years of experience working in a microbiology laboratory.
• Must have a BS degree in microbiology or other science-related degree.
• Must have a thorough knowledge of all cGMP and Quality Assurance requirements
• Must have knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications
• Must be able to read, write and understand the English language.
• Must be able to identify complex problems and review related information to develop and evaluate options and implement solutions; must have good time management skills; must be able to multi-task to meet required deadlines.
• Work involves walking, talking, hearing, using hands to handle, feel, or operate objects, tools, or controls, and reaching with hands and arms. Vision abilities required by this job include close vision and distance vision. Sit at a desk for long periods of time in front of a computer screen; intermittently twist to reach equipment or supplies surrounding desk; use telephone and computer keyboard daily; must be able to read to perform work according to specified written instructions and procedures. May routinely require the employee to balance, bend, stoop, kneel, and crouch lifting occasionally 1 to 25 pounds, push and rotate a variety of containers. Must be able to perform the same action for items weighing over 50 pounds with assistance, must perform work while wearing required personal protective equipment, i.e. respirators, eye protection, gloves, arm protection, safety shoes and hearing protection when required.
• Must be able to operate the laboratory equipment, e.g. autoclaves, Vitek identification system, etc., and do so in a safe manner.