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).
Skills Required
- Bachelor’s or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
- Bachelor’s degree with 3 years of progressively responsible experience in pharmaceutical or biologics production environments, or a master’s degree with 0–3 years of experience, or equivalent combination of education and experience.
- Working knowledge of GLP and cGMP regulations, including 21 CFR Parts 11, 210, 211, and 600, applicable 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.
- Ability to consistently adhere to good documentation practices.
- Strong attention to detail and written and verbal communication skills.
- Ability to work independently within prescribed guidelines and as a team member.
- Willingness to work in cleanroom settings and handle biohazardous materials using proper PPE and gowning protocols.
- Experience with Microsoft Excel, Word, and PowerPoint.
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.
