Senior Analyst, Quality Control Microbiology

·          Support Quality Control testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines

·          Perform bioburden, endotoxin, pH/Conductivity and other tests as needed

·          Perform viable air, non-viable particulate, surface/swab environmental monitoring (EM) of manufacturing areas

·          Perform sampling and testing for gas, utilities and purified water

·          Perform growth promotion/media qualification, Gram staining and microbial cryopreservation

·          Perform plate reading, generate microbial isolates, and shipping of isolates for identification

·          Receive, unpack and organize supplies for QC areas

·          Revise SOPs, Forms and approved documents

·          Perform/support deviation and OOS investigations, as needed

·          Support the identification and implementation of effete CAPAs

·          Support testing and assist in writing of method validation, assay development, routine, and non-routine study protocols

·          Support Fill and Finish operations

·          Assist in data trending and summarization

·          Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance to cGMP

·          Perform data review and microbial assessment

·          Support special projects and continuous improvement efforts

·          Provide training and technical leadership to less experienced staff

 

 

About you

Must Have/Required  

·           Bachelor’s Degree in chemistry, biology, or microbiology with 5+ years’ relevant microbiology laboratory experience in Pharmaceutical/Biotech. 

·           Excellent knowledge of Aseptic technique and common microbiological testing

·           Knowledge of relevant, compliance and guidance documents

·           Must be able to gown into cleanrooms in support of testing and manufacturing activities

·           Good documentation (ALCOA +) and data organization

·           Detail oriented and willingness to learn and follow instructions

·           Interpersonal skills and ability to contribute to the success of a team

·           Proven history of working in a fast-paced team environment, time management, and meet deadlines.

·           Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed

·           Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required

·           Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Must be proficient in use of computer, particularly Microsoft Word and Excel programs, and be able to sit/stand and be gowned inside the cleanroom for extended periods of time. Some lifting required (not more than 50 lbs.). Ability to tolerate the smell of Gram negative organisms and disinfectants (i.e. 1% bleach, sporeklenz) may be needed. Use of a respirator may be required. Exposure to biohazards and viruses. Routinely able to stand, walk, kneel and crouch while performing sampling, such as environmental monitoring.