Microbiologist

Trident Consulting is seeking an experienced Microbiologist I/II for one of our direct clients in Aliso Viejo, CA.

Title : Microbiologist I/II

Location: Aliso Viejo, CA- onsite

Contract w2

Microbiologist I level 1 - $38.94 - $48.65

Microbiologist II level 2 $50 -$57/hr on w2

Candidate should have:USP compendial testing working knowledge of cGMP, GLP, GDP and laboratory safetyMedical device / pharmaceutical

Description

Microbiologist I/II Job Description:

• The Microbiologist I/II is responsible for performing routine microbiological testing of raw materials, in-process samples, finished product and performing stability testing activities in accordance with current Good Manufacturing Practices (cGMP), company procedures and applicable regulatory standards.
• This role is expected to work independently, support and perform method development, method validation and method transfer activities.
• This exciting role will support microbiological activities for the organization, which includes R&D as well as commercial manufacturing.
• The candidate must have experience in cGMPs, regulatory body requirements and FDA compliance.
• The candidate must be proficient in microbiological testing per USP/EP/JP.
• The ideal candidate would be versatile, flexible, extremely organized, ability to adapt to project demands and ability to prioritize work to meet timelines.
• The candidate must aseptic processes and manufacturing.

Responsibilities:

• Perform routine microbiological testing of raw materials, in-process samples, finished products, and stability samples.
• Perform microbial enumeration, antimicrobial effectiveness testing, sterility testing, bioburden testing, endotoxin testing, and growth promotion testing as applicable.
• Prepare microbiological reagents, media and order and maintain laboratory supplies.
• Assist with laboratory organization, inventory management, and maintenance of laboratory supplies and equipment.
• Perform laboratory equipment operation, calibration, maintenance, and routine troubleshooting.
• Maintain accurate laboratory notebooks, test records, and electronic documentation in accordance with cGMP and Good Documentation Practices.
• Maintain complete and accurate documentation of all microbiological activities, including test results, procedures, and reports.
• Review test results and notify management of out-of-specification (OOS), out of trend (OOT) or atypical findings .
• Follow approved Standard Operating Procedures (SOPs), laboratory safety practices, and aseptic techniques Participate in laboratory investigations, deviations, CAPAs, and change control activities as assigned.
• Perform testing to generate data for validation activities, stability studies and special projects Collaborate with Quality Assurance, Manufacturing, Engineering, and R&D to support production and quality initiatives.
• Maintain compliance with FDA, ISO, USP, and other applicable regulatory requirements.

Additional Responsibilities

• (Microbiologist II) Assist in microbiological method development, method verification, method transfer, and method validation activities.
• Prepare or revise SOPs, test methods, validation protocols, and technical reports Support qualification of laboratory equipment (IQ/OQ/PQ).
• Perform data review and trend analysis of microbiological results and recommend process improvements.
• Train and mentor new laboratory personnel.
• Coordinate and oversee microbiological testing with qualified contract laboratories, oversee suppliers and contract laboratory performance, review test results and documentation, and ensure testing activities comply with applicable quality and regulatory requirements.
• Support internal and external audits and regulatory inspections Participate in continuous improvement initiatives and laboratory projects

Requirements

• Proficiency in microbiological techniques such as microbial enumeration, growth promotion, sterility testing, bioburden testing, antimicrobial effectiveness testing and bacterial endotoxin testing.
• Proficiency in testing according to AAMI/ISO/USP Standards; USP <51>, <61>, <62>, <71>, <85>; working knowledge of cGMP, GLP, GDP and laboratory safety .
• Knowledge and control of laboratory equipment including calibration and maintenance.
• Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices.
• Understanding of quality systems including change control, deviations and CAPAs; support investigations as needed Ability to handle multiple tasks concurrently and complete tasks in a timely manner
• Strong written and verbal language skills to effectively read and write SOP’s and related lab reports and effective communication skills to present data with personnel at all levels in the organization.
• Excellent teamwork skills, organizational skills, and strong attention to detail Knowledgeable in regulatory requirements and industry standards related to microbiology.
• Proficient in using microbiological testing equipment and software; Knowledge and proficiency in computer software (e.g. Microsoft Office programs).
• Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem-solving abilities to interpret test results, troubleshoot issues, and recommend solutions
• Ability to work collaboratively in cross-functional teams and adapt to changing priorities and deadlines Strong organizational and time management skills to prioritize tasks and meet project timelines.

Required Qualifications:

Bachelor's degree in Microbiology, Biology or related scientific field Minimum 5 - 8 years of related pharmaceutical experience in a cGMP environment

Physical Requirements :

Ability to lift 25 lbs. Ability to stand or sit 8 or more hours a day Work in a sterile environment wearing appropriate gowning and protective equipment