Quality Control Scientist I

Purpose & Scope

QC Scientist, Microbiology will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program, and microbial testing. QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members. This role is scheduled for Monday to Friday First shift (8 am to 5 pm) supporting GMP operations.

Role and Responsibilities

• Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
• Reviews EM, lab test results, and documents for product testing, EM, and trend reports.
• Oversee the trending and reporting of environmental data.
• Be an SME/Trainer for microbial testing of media release, products testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
• Be an SME for EM/lab assays and help with assay qualification, instrument troubleshooting, and procedure/report writing.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• Author any non-conformance, deviations, and OOS investigations-work with the team to find a root cause and corrective actions for out of specification results.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at contract labs and CMOs.
• Support QC equipment validation, maintenance, calibration, and QC laboratories scheduling and maintenance.
• Participate and own technical projects/documents for process improvement and implementation, experience with rapid assays (CCIT, Mycoplasma, and Sterility) is required.
• Represent QC in cross functional meetings and provide support/feedback for microbial quality/contamination control of the facility.
• Collaboratively develop and maintain the facilities contamination control strategy.

Required Qualifications

• B.S. degree in Biology/Microbiology with 8 years or MS with 4 years of relevant industry experience in a QC lab.
• Demonstrated experience of aseptic techniques and common microbiological testing.
• Supports/Mentors routine work, help/coach the team for testing or technical documents/projects
• Good documentation, data organization, detail oriented, and for quality and timely batch release.
• Must be capable of observing and adhering to lab safety standards and procedures
• Excels in a fast-paced team environment and completes assigned work in timely fashion.
• Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment
• This role is scheduled to work during day shift (8 am to 5 pm) on Monday to Friday and flexibility may be required to support GMP Operations.

Preferred Qualifications

• Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
• Model our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and Compliance.

Location and Working Environment

• This role frequently requires long hours of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting to 35lbs.
• Requires gowning inside the cleanroom for extended periods of time.
• Use of gloves and mask is required to prevent exposure to biohazards and viruses.
• This is an on-site role working in a cGMP regulated manufacturing facility.