Laboratory Analyst to III – Medical Device and Drug Delivery Systems

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 tomedical device and drug delivery system 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.

Specific knowledge of relevant ISO standards for medical device packaging and drug delivery systems, including hands-on experience with testing contained within

• ISO 11607 – Sterile Packaging
• ISO 11040 – Prefilled Syringes
• ISO 80369 – Luer Connectors

The unique overlap between ISO and GMP/USP/Compendial testing for combination products where the drug delivery device is also a primary package system.

• For example, overlap with USP , , , etc.

The following instrumentation / software

• Instron Bluehill Universal
• Keyence IM Dimensional Analysis
• Hand tools – force gauge, caliper, durometer, thickness, etc.

Tests contained in standards above, including:

• Break loose and glide force
• Flange breakage
• Needle shield removal
• Lockout override force
• Luer connector torque

Concepts related to Container Closure Integrity and Packaging and Distribution Simulation highly additive to this role

General Responsibilities – Applicable to all Levels

• 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.

Analyst I Responsibilities

• 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.

Analyst II Responsibilities

• 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.

Analyst III Responsibilities

• Assumes responsibility as system owner for a broader range of more complex instrumentation, responsible for maintaining SOPs, ERs,…