Laboratory Analyst to III – Container Closure Integrity; CCI

Operating in CS Analytical’s cGMP, FDA-registered laboratory in Clifton, NJ, Laboratory Analysts are responsible for executing client testing and supporting overall laboratory operations. The position ranges from Analyst I to III, with senior levels (Analyst III) responsible for bringing an advanced level of technical experience to independently execute projects, author protocols and reports, and support junior staff.

This specific position is specific to container closure integrity (CCI), or leak testing, and requires familiarity with at least some of the following concepts. Specific position (I through III) to be dependent on candidate experience and ability to fulfill required job functions. Duties and responsibilities, listed below for Analyst I through III, would be within this scientific focus.

• Helium Leak Detection
• Headspace Analysis
• HVLD
• Dye Ingress

• Positive controls
• Method development and validation
• CCI over the product lifecycle
• Sealing qualifications and related tests and concepts, such as dimensional stackups, RSF, compression, etc.
• Impact of variables such as temperature, altitude, shock and vibration, etc.

• Vials with liquid and solids, including lyo
• PFS, including in NSD or AI
• Cartridges
• IV bags

• Maintains the cleanliness of their immediate work environment.
• Works with Lab, QA, and Business Operations to ensure chemical, materials, and supplies are available by inventorying stock, placing orders upon request, and verifying receipt.
• Assists with sample intake, disposal, shipping, and receiving as required.
• Documents all information by maintaining LIMS records, electronic lab notebook entries and Qualio documents, such as ERs, as necessary.
• Updates job knowledge by participating in educational opportunities, seeking training on new instruments or test methods, and reading relevant industry guidance or documentation.
• Accepts ownership for accomplishing new and different requests and exploring opportunities to add value to overall laboratory operations.

• Assists with equipment by performing daily performance verification or system suitability, preventive maintenance, qualification, and calling for repairs when necessary.
• Performs laboratory housekeeping tasks, inclusive of glassware washing, as assigned.
• Independently performs and documents solution preparation, sample preparation, and basic measurements or analyses as assigned.
• Follows established TMs, WIPs, and/or Protocols under the guidance and direction of senior laboratory peers or management.
• Assists with protocol, method, and report writing, data analysis, and summarization.
• May contact clients for updates or clarifications as instructed by a project lead or laboratory management.

• Assists with equipment operation by performing daily performance verification or systems suitability, preventive maintenance, and calling for repairs when necessary.
• May act as system owner for laboratory equipment, responsible for maintaining SOPs, ERs, calibration, qualification, etc., inclusive of new systems being introduced.
• Independently performs and documents solution preparation, sample preparation, and basic measurements or analyses as assigned.
• Follows established TMs, WIPs, and/or Protocols under the guidance and direction of senior laboratory peers or management.
• Supports drafting of protocols, methods, report writing, data analysis and interpretation.
• May contact clients for updates or clarifications as instructed by a project lead or laboratory management.

• Assumes responsibility as system owner for a broader range of more complex instrumentation, responsible for maintaining SOPs, ERs, calibration, qualification, etc., inclusive of new systems being introduced.
• Scopes new work from a technical perspective, supporting lab management and Business Operations to determine and acquire supplies for the study.
• Independently authors technical protocols, WIPs, and test methods, coordinating internally and…