The Sr. Quality Analyst, Sterility Assurance is responsible for QC microbiological aspects of cGMP compliance and testing ensuring microbiological quality of products, manufacturing process areas, and facility/utilities.
Responsible for QC microbiological aspects of cGMP compliance and testing.
Assist in the identification of microbiological root cause analysis and provide technical advice required.
Participate in the investigation and review of alert/action limit investigations and implement corrective action as appropriate.
Participate in validation activities involving microbiology as needed.
Participate in the investigation of microbiological product OOS results as required.
Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Assist in the review of EM and product release data.
Microbiology representation and participation in cross functional site meetings.
Initiates and completes CAPAs and Change Controls in accordance with site procedures.
Proactively identifies and implements lab process improvements, lean initiatives.
May be required to observe manufacturing operations on the floor to provide constructive feedback for strengthening microbial controls and aseptic practices.
Support roll out of relevant training and/or provide coaching to personnel related to Microbiology and Microbiological controls
Ensure all work performed is in compliance with required regulatory standards, conforms to company policies and SOPs.
Participate in inspections for regulatory/internal/corporate audits.
Support other duties assigned by QA Microbiology management as required
Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
Support Microbiology projects as needed.
Prepare and analyze trend analysis reports microbiology test data (EM, PM, water, etc.).
Support LIMS system for data entry and approval.
Review and approve laboratory documentation.
Bachelors/Masters in Microbiologypreferred. 5+ years of relevant experience preferably in a QC Microbiology Laboratory within the pharmaceutical or biotechnology industries.
Knowledge of sterile products manufacturing processes and testing preferable. Knowledge of aseptic manufacturing processes is ideal.
Excellent communication skills, both verbal & written.
Adaptable and flexible.
Collaboration and team work.
Results and performance driven.
Good time management and attention to detail.
Maintains the highest standards of ethical behavior.
Experience with electronic systems such as LIMS, CATSWeb etc., is ideal.
Knowledge and proficient in the use of Excel, Word and Powerpoint.
Strong analytical ability and associated problem solving.
Knowledge of current industry microbial aseptic practices required.
Must be able to enter and work in classified environments.