Quality Control Scientist II

Job Description

Job Description

6 Months contract

• 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.

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.

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Company Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.