Senior Quality Control Analyst

Salary Range: 90000 to 210000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Responsible for performing microbiological testing of raw materials and cell therapy products in accordance with organization’s policies and SOPs
• Serve as a deputy for the QC Microbiology Manager during absences, ensuring continuity of operations and decision-making, flexibility to handle additional responsibilities and dynamic situations
• Responsible for performing routine and non-routine microbiology testing such as B&F and sterility test, bioburden testing, growth promotion testing of purchased media (iNST & iAST bottles, TSA RODAC and Settle plates, etc.) bacterial endotoxin method development/verification and routine testing, gram stain, microbial readings, investigational testing
• Ability to work effectively within controlled environments under cGMP regulations, responsible for overseeing and maintaining gowning qualification program
• Participate in aseptic process simulation activities (APS)
• Support method qualification and transfer activities and participate in validation of microbiological methods commensurate with experience
• Conduct Environmental Monitoring of controlled environments (ISO 5 production isolators, ISO 8 cleanrooms, CNC) including non-viable and viable air particulate, surface viables in a GMP manufacturing facility
• Participate in EMPQ activities, assist in developing sampling plans and routine EM program for new cGMP cleanrooms and adjacent controlled areas as per ISO and other regulatory requirements
• Conduct utilities monitoring of compressed gas systems including CDA, N2, CO2 (non-viable and viable air particulate) in a GMP manufacturing facility
• Responsible for training of team members for GMP testing; effective communicator and deep technical expertise in key microbiology assays, to be able to share and communicate that knowledge through training of analysts
• As a senior team member responsible for providing technical support and guidance to lab staff, assisting with troubleshooting and experimental design, leading investigational studies
• Responsible for authoring trend reports for EM and utilities, also review reports that are generated and make conclusions as to any action required based on the data
• Document results accurately in laboratory notebooks, LIMS, ELN, and batch records
• Perform timely and accurate peer review of test results/reports, compile and review data to ensure accuracy and regulatory compliance
• Collaborate with cross functional teams to develop and execute process improvement strategies ensuring alignment with organizational goals
• Responsible for development and management of SOPs, forms, and method protocols/reports required to support compliant operation and testing conducted in the microbiology laboratory
• Communicate effectively with management regarding road needs, task completion and issues related to QC Microbiology division
• Investigate and document non-conforming events, OOS and EM excursions
• Provide expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations and change management processes
• Support Quality Systems such as change control, deviation, CAPA, audits, quality metrics, etc.
• Responsible for reviewing all data in compliance with applicable procedures and cGMP requirements as well as data integrity principles
• Interface with contract testing laboratories a technical expert (e.g. microbial identification services)
• Prepare COA/COT for testing performed
• Participate in internal assessments and audits as required, supply quality control data necessary for regulatory submissions
• Support equipment validation, calibration, maintenance, and troubleshooting
• Maintain lab inventory, ensuring proper stock levels of media, reagents and consumables to support uninterrupted operations
• Assist in maintaining a clean and safe laboratory environment, adhering to all safety and compliance requirements
• Perform other duties as assigned

Requirements

• B.S. degree in a science discipline required, or comparable experience
• 5+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
• Prior experience with EMPQ, Environmental Monitoring and microbiological assays (endotoxin, sterility)
• Familiarity with rapid microbiology technology such as BAC-T, Nexgen-MCS is highly preferred
• Sterility and endotoxin method qualification and transfer experience is highly preferred
• Good adherence with current Good Manufacturing Practices (cGMP), ISO regulations (ISO 14644), USP chapters, FDA regulations and understanding of 21 CFR, USP, EP and FDA microbiology testing requirements
• Experience in participating in audits and providing audit requests (internal and external including regulatory inspections)
• Deep understanding of contamination control and aseptic processes, Knowledge of cleanroom classifications and requirements (ISO 5-8), ability to work in a cleanroom environment and adhere to gowning protocols
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Must be able to commute to Bridgewater, New Jersey
• Excellent verbal, written, organizational, presentation and interpersonal skills
• Self-awareness, integrity, authenticity, and a growth mindset