Quality Control Scientist

Zenith LifeScience; Westborough (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Zenith LifeScience is seeking a Scientist II QC Microbiology to serve as a senior technical SME overseeing microbiological testing programs for GMP operations. You will mentor staff, support quality systems, and deliver aseptic technique training to maintain contamination controls.

The role requires leading cross-functional efforts, reviewing data and documentation, and collaborating with Manufacturing, QA, and Facilities to drive process improvements while ensuring compliance with cGMP

Qualifications

• BS degree in Biology/Microbiology with 10+ years or MS with 6+ years in GMP QC microbiology.
• Advanced expertise in microbiological testing including environmental monitoring, bioburden, endotoxin, sterility, mycoplasma, and microbial ID.
• Experience in aseptic manufacturing environments and cleanroom operations.
• Experience mentoring staff and providing technical training.
• Strong knowledge of cGMP regulations and microbiological control strategies.
• Excellent technical writing and communication skills.
• Collaborative, cross-functional teamwork with a positive work environment.

Responsibilities

• Serve as SME for microbiological testing programs including environmental monitoring and contamination control.
• Support QC Microbiology Senior Manager in lab operations and program execution.
• Aseptic technique and contamination control training for manufacturing and QC personnel.
• Track deviations, investigations, CAPAs, Change Control and trending for QC microbiology.
• Review and approve microbiological data, SOPs, protocols, and reports.
• Lead data trending and interpretation to identify risks for contamination control.
• Provide mentorship to microbiologists and junior scientists.
• Author and review GMP-compliant SOPs, protocols, and validation reports.
• Lead or support method qualification, validation, and tech implementation.
• Collaborate with Manufacturing, QA, Facilities to support operations and improvements.
• Support regulatory inspections and responses with technical justification.

Skills

Microbiological testing expertise

Environmental monitoring

Bioburden

Endotoxin testing

Sterility

Mycoplasma testing

Microbial identification

Aseptic manufacturing

Cleanroom operations

Mentoring staff

cGMP knowledge

Technical writing

Communication skills

Education

BS in Biology/Microbiology

MS in Biology/Microbiology

Job 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.

Job 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.