Senior Associate I, QC Microbiology

Tanvex BioPharma Inc.; San Diego (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Tanvex BioPharma Inc. in San Diego, CA, is seeking a Senior Associate, QC Microbiology to perform and review routine environmental and utilities monitoring of cGMP facilities.

You will conduct microbiological and chemical testing (endotoxin, bioburden, TOC, conductivity), support method validation, and draft protocols, reports, and SOPs. You will trend data, report results timely, participate in investigations, and collaborate with Manufacturing, QA, and Validation teams to ensure product

Qualifications

• BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
• 3 years in pharma or biologics production environments with BS, or MS with 0-3 years.
• Experience with GLP and cGMP, 21 CFR Part 11.

Responsibilities

• Perform Bioburden and endotoxin testing of in-process and products samples.
• Environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Revise SOPs and Test Methods as required.
• Review data generated in the Microbiology lab.
• Execute method suitability testing, performance qualifications and various studies.
• Conduct investigations of microbiological Quality Events and support CAPA implementation.
• Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
• Author quarterly and yearly trend reports.
• Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.

Skills

GLP/cGMP knowledge

Microbiology techniques

Data trending

Documentation practices

Communication skills

Education

BS in Microbiology or Life Sciences

Tools

Laboratory equipment

Microsoft Office

Job description

Description

The Senior Associate, QC Microbiology is responsible for performing and reviewing routine environmental) and utilities monitoring of the cGMP manufacturing facilities. Conduct review of microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include performing data trending, supporting method validation activities, and the drafting of protocols, reports, and SOPs related to microbiological operations. The role also involves timely and compliant reporting of test results and participation in investigations as needed.

Job Responsibilities:

• Perform Bioburden and endotoxin testing of in-process and products samples.
• Environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Revise SOPs and Test Methods as required.
• Review data generated in the Microbiology lab.
• Execute method suitability testing, performance qualifications and various studies.
• Conduct investigations of microbiological Quality Events and support CAPA implementation.
• Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
• Author quarterly and yearly trend reports.
• Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.
• Other duties as assigned.

Requirements

Education and Experience

• BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
• BS with 3 years or MS degree with 0-3 years of progressively responsible experience in pharmaceutical or biologics production environments, or equivalent combination of education and experience.

Knowledge, skills and abilities

• Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
• Knowledge of standard laboratory equipment.
• Basic understanding of microbiological techniques, aseptic practices, and laboratory safety.
• Good organizational and problem-solving skills.
• Ability to follow written procedures and work in a regulated environment.
• Must always adhere to good documentation practices.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols.
• Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel).