Quality Control Scientist II

Description
The Scientist II QC Microbiology serves as senior technical subject matter expert
responsible for overseeing microbiological testing programs supporting GMP
operations. This role provides technical leadership across QC Microbiology and
Manufacturing by ensuring effective microbiological testing, mentoring laboratory staff,
supporting quality systems and delivering aseptic technique training to maintain
compliance with GMP and contamination control requirements.

Responsibilities:
" Serve as subject matter expert for microbiological testing programs including
environmental monitoring, sterility, endotoxin, mycoplasma, microbial identification, and
contamination control.
" Support QC Microbiology Senior Manager in oversight of laboratory operations,
technical initiatives, and microbiological program execution.
" Develop and deliver aseptic technique and contamination control training for
manufacturing and QC personnel to maintain compliance with GMP and cleanroom
practices.
" Track and support quality system activities including deviations, investigations, CAPAs,
Change Control and trending associated with QC microbiology operations.
" Review and approve microbiological data, protocols, quarterly reports , SOPs and
other technical documentation.
" Lead data trending and interpretation of environmental monitoring and microbiological
data to identify risks and support contamination control strategy.
" Provide technical leadership and mentorship to microbiologists and junior scientist
within QC microbiology laboratory.
" Author and review SOPs, protocols, validation reports, investigation reports and
technical documents in accordance with GMP requirements.
" Lead or support method qualification, validation, and technology implementation for
microbiological assays.
" Collaborate cross-functionally with Manufacturing, QA , Facilities and other teams to
support manufacturing operations and process improvements.
" Support regulatory inspections, audits and responses by providing technical
justification and documentation.

Required Qualifications
" BS degree in Biology/Microbiology with 10+ years or M.S. with 6+ years of relevant
experience in a GMP QC microbiology laboratory.
" Demonstrated advanced expertise in microbiological testing including environmental
monitoring, bioburden, endotoxin, sterility, mycoplasma and microbial identification.
" Experience supporting aseptic manufacturing environments and cleanroom
operations.
" Demonstrated experience mentoring laboratory staff and providing technical training.
" Strong knowledge of cGMP regulations and microbiological control strategies.
" Excellent technical writing and communication skills.
" 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) Monday to Friday.
" Flexibility to work weekend hours may be required to support GMP Operations.