QC Analyst III

Katalyst CRO; Portsmouth (NH); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a Quality Microbial Control Analyst V to join our team. The role supports production of in-process and final product drug lots, participates in stability testing, and ensures timely, high-quality results aligned with manufacturing demands.

The ideal candidate will apply GMP knowledge, perform method transfers and CAPA-related tasks, and act as a subject-matter expert across the department. This on-site role emphasizes data integrity and quality record writing.

Competenze

• Bachelors in Microbiology, Biochemistry, or related field.
• 510 years of relevant QC Micro experience in GMP.

Mansioni

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility
• Reviewing assays.
• Training others.
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects such as method transfers, new instruments, method qualifications.
• Use of Microsoft Suites (Word, Excel, PowerPoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Back-up to Supervisor Independently making quality decisions with input

Formazione

Bachelor's degree in Microbiology, Biochemistry, or related field

Strumenti

TrackWise

LIMS

Microsoft Office (Word, Excel, PowerPoint)

Descrizione del lavoro

Job Description

The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. May be assigned to work on special projects. Also may provide support to others in the absence of the supervisor. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Acts as an area SME providing technical support within the department and throughout the facility.

Job Description

The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. May be assigned to work on special projects. Also may provide support to others in the absence of the supervisor. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Acts as an area SME providing technical support within the department and throughout the facility.

Responsibilities

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility
• Reviewing assays.
• Training others.
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects such as method transfers, new instruments, method qualifications.
• Use of Microsoft Suites (Word, Excel, PowerPoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Back-up to Supervisor Independently making quality decisions with input

Requirements

• Bachelors in Microbiology, Biochemistry, or related field.
• 510 years of relevant QC Micro experience in GMP.