Quality Control Microbiology testing

Job Title: Quality Control Microbiology testing

Location: Pearl River, NY

About The Job:

The function of this position is to perform microbiological testing and related analytical functions in the QC microbiology lab. This position includes performing microbiological and other testing following approved methodology to assure that the safety, quality, purity and stability (as appropriate) of our systems products, components and in- process stages are in compliance with approved specifications. Additionally, this position provides input for data trending and assists with or authors periodic reports as necessary, highlights problems related to technical and equipment issues, and works closely with the Microbiology Manager.

The microbiology team is highly flexible and provides cross functional support as part of manufacturing processes and quality investigations. This role allows opportunity to become multi skilled with the team and gain experience/skills within all areas essential to working within an operational microbiology laboratory.

Main Responsibilities:

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to perform the assigned analytical testing on a variety of samples (e.g. raw materials, in-process drug substance samples, environmental monitoring, etc.)
• Performing the QC data review of executed tests by other analysts in a timely manner based on managerial delegation, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx,...) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively in any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

Key Roles (D,A,I)

• Build remediation plans related to inspection readiness gaps, findings, deviations, ... (A)

Additional Accountabilities

• Contributing to trending of environmental monitoring and utilities monitoring data and assisting with/authoring periodic reports as necessary
• Training team members in analytical testing and documentation upon trainer qualification, ensuring adherence to local and global standard operating procedures and cGMP requirements
• Ensuring the laboratory is maintained in an audit-ready state at all times and represent the lab team during audits/inspections
• Revising and updating local procedures as necessary to align with cGMP/cGLP guidelines and enhance ease of use for laboratory activities

About You:

Basic Qualifications:

• Bachelor's degree in Life sciences, Biology, Chemistry or related field.
• 1+ Years of laboratory or manufacturing experience.

Preferred qualifications:

• Experience in a pharmaceutical or related industrial environment.

The salary range for this position is:
$69.000,00 - $99.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.