Laboratory Analyst I to III – Medical Device and Drug Delivery Systems
hace 1 día
Clifton
Job Overview 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 medical 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 11608 – Needle Based Injection Systems (Autoinjectors), • ISO 11040 – Prefilled Syringes, • ISO 7886 – Sterile Hypodermic Syringes, • ISO 7864 – Sterile Hypodermic Needles, • 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 <382>, <1207>, <660>, etc. The following instrumentation / software • Instron Bluehill Universal, • Keyence IM Dimensional Analysis, • Torque meter, • Hand tools – force gauge, caliper, durometer, thickness, etc. Tests contained in standards above, including: • Needle penetrability, • Breakloose and glide force, • Syringe burst strength, • 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, 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 externally for document approvals., • Performs basic and complex analyses and measurements, inclusive of development, R&D, and internal projects and investigations., • Acts as primary laboratory representative for quality events and investigations such as deviations, OOS, OOT, etc., • Oversees and supports more junior staff with day-to-day operations, training, and requests for assistance., • Performs laboratory peer review of analyst work., • Contacts clients for updates or clarifications as instructed by a project lead or laboratory management. Qualifications All levels require at least some of the concepts outlined in the job overview. General qualifications for Laboratory Analyst I through III are below. Analyst I • Past experience as a CS Analytical Laboratory Technician OR, • High school diploma or equivalent required, Associates degree or higher preferred, • Past work experience in a laboratory setting preferred, • Familiarity with basic lab equipment such as pipettes and balances preferred, • Familiarity with basic chemistry techniques such as preparing solutions at certain concentrations, • Attention to detail, • Ability to adhere to procedures and guidelines associated with a cGMP, FDA-registered environment Analyst II • Past experience as a CS Analytical Laboratory Analyst I OR, • Past work experience in a laboratory setting required, cGMP preferred, • Familiarity with lab equipment, both basic and more advanced, • Past experience with or knowledge of test standards relevant to CS Analytical, • Attention to detail, • Ability to adhere to procedures and guidelines associated with a cGMP, FDA-registered environment Analyst III • Past experience as a CS Analytical Laboratory Analyst II OR, • Associates degree required, bachelors preferred, advanced degree prioritized, • Past work experience in a cGMP laboratory required, • Advanced experience or knowledge of test standards and instrumentation relevant to CS Analytical, • Past experience with or knowledge of test standards relevant to CS Analytical, • Attention to detail, • Ability to adhere to procedures and guidelines associated with a cGMP, FDA-registered environment This is NOT a remote position. You will be working onsite at our Clifton, NJ facility. To Apply, please send a cover letter and resume to
