QC Analyst II *PC in San Jose, California

Job Title

This position is primarily responsible for the complete development, qualification and performance of environmental monitoring and microbiological QC assays to support GMP manufacturing operations in a Phase I/II multi-product biologics facility.

Essential Duties and Responsibilities:

• Develop and execute environmental monitoring in ISO5/7/8 clean rooms
• Develop and execute microbiological assays, such as sterility.
• Adhere to all applicable SOPs for clean rooms, quality control and quality assurance
• Develop GMP documentation such as, trend reports, SOPs and documents to support equipment operation.
• Responsible for the proper maintenance and use of equipment in strict accordance with cGMPs, SOPs and safety policies.
• Lead EM Investigations.
• Serve as a key resource as it relates to establishing EM testing requirements.
• Trend EM Data and investigate all OOL specifications. Identify counts and assist in investigating and implementing appropriate CAPA.
• Work with QA, Manufacturing, Development and others to troubleshoot issues.
• Ensure adherence to EM schedule.
• Develop and Implement training plans for QC EM Analyst I on the EM Program.
• Train manufacturing and QA team members on EM program requirements.
• Ensure quality standards are always met or exceeded.
• May assist in audits.
• Other duties as assigned.

Requirements:

• B.S. Biology, Chemistry, Biotechnology, or related field; 2+ years of experience in environmental monitoring.

Knowledge / Skills / Abilities:

• Knowledge of cGMP or GLP regulations is essential.
• Comprehensive GMP environmental monitoring experience is required.
• Previous experience working in QC department of Biotech Company is preferred and, as is impeccable aseptic technique.
• Experienced with MS Office. specifically, Word, Excel and PowerPoint.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.

While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.