Description
Summary
The Quality Control Associate I, Microbiology is responsible for performing routine environmental and utilities monitoring of the cGMP manufacturing facilities. Conducts microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include assisting with data trending, supporting method validation activities, and contributing to 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
Essential Functions
- Conduct Bioburden and endotoxin testing of in-process and products samples.
- Perform environmental monitoring (EM) of classified cleanrooms and controlled areas.
- Collect and test water samples from purified water and WFI systems.
- Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs.
- Assist in investigations of microbiological deviations and support CAPA implementation.
- Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
- Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.
Supplemental Functions
- 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 0-2 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).
Skills Required
- BS or advanced degree in a related scientific discipline (or equivalent experience)
- 0-2 years experience in pharmaceutical or biologics production environments (or equivalent)
- Working knowledge of GLP and cGMP regulations and good documentation practices (21 CFR Part 11, 210, 211, 600 & EU guidelines)
- Experience performing bioburden and endotoxin testing
- Experience with environmental monitoring of classified cleanrooms and controlled areas
- Experience collecting and testing purified water and WFI system samples
- Ability to maintain accurate compliant documentation in accordance with SOPs and regulations
- Ability to assist in microbiological investigations and support CAPA implementation
- Knowledge of standard laboratory equipment and basic microbiological techniques, aseptic practices, and laboratory safety
- Willingness to work in cleanroom settings and handle biohazardous materials with proper PPE and gowning
- Experience with Microsoft Office suite (PowerPoint, Word, Excel)
- Strong attention to detail, written and verbal communication, organizational and problem-solving skills
What We Do
Tanvex Biopharma USA, Inc is a biologic pharmaceutical product development and manufacturing organization aiming to provide high quality, value added capabilities to accelerate the introduction of biologic therapeutics to the global market.
