The following website advertisement will be posted from
01/02/2024 – 01/26/2024
Lab Equipment Validation Consultant w/Master’s degree or Foreign Equivalent in Engineering - Mechanical Engineering Option or Mechanical Engineering or Industrial Engineering or Manufacturing Engineering and one (1) year experience as Lab Equipment Validation Consultant or Mechanical Engineer performing following job duties:
Validate/Qualify equipment, systems, computer systems and processes in accordance with regulatory requirements Food Drug Administration (FDA part 11,210,211 820) and company manufacturing standards. Develop and execute protocols for qualification of Laboratory and Manufacturing support systems and process equipment (Installation, Operational & Performance) protocols in accordance with GxP regulations. Develop, review, approve Validation lifecycle documentation and execute in compliance with GAMP5 regulations and 21 CFR Part 11 enforced by US FDA. Perform Installation and Operational qualification for Refrigerator, -200C Freezer, Cryogenic Freezers and LN2 Tanks used for Product/In-process material storage. Responsible for Validation records and reports for equipment (Bioreactors, Freezers and Incubators).Salary: $105539.00 Per Year.
- Compile and analyze financial information.
- Analyze financial information detailing assets, liabilities and capital and prepare balance sheets, profit and loss statements, and other reports to summarize current and projected company financial reports.
- Establish, modify, document and coordinate implementations of accounting and accounting control procedures.
- Apply principles of accounting to analyze financial information and prepare financial reports.
- Devise and implement manuals for general accounting
- Train and support all staff in appropriate financial modules in the Sage MAS200 Accounting System such as Inventory, A/R, A/P, G/L, P/O, S/O
- Ensure smooth day to day financial operations such as invoicing, collections, customer statements, system month end, weekly and monthly reporting.
- Review and recommend modifications to accounting systems and procedures
- Study accounting documents to ensure accuracy of information and calculations and make or direct corrective entries
- Proficiency in troubleshooting user issues in various distribution and accounting systems such as Sage MAS200, Peachtree, QuickBooks Premier and Online Enterprise, MSOffice.
- Preparing daily, weekly and monthly Borrowing Base Certificate [BBC] and related worksheets for reporting to financial institutions as per loan agreements and procedures
- Credit insurance monitoring with companies such as Euler Hermes and CNA and reporting for all customers.
- Worked with in-house team and NYC Industrial Development Authority to comply as an IDA project to get incentives of 1.2M $.
- Responsible for working with auditors from NYC IDA, banks and SBA on a regular basis to assist them with field audits and provide them with all necessary financial and business information to prepare reports such as BBC and related obligations.
- Develop accurate financial forecasts and targets, tracking accountability and reporting requirements
- Maintain journal entries and all general ledgers and ensure bank reconciliation of all statements as per GAAP.
- Ensure documentation provided by corporations meets the audit guidelines of GAAP
- Identify and implement process improvements across the finance organization to drive simplification and allow improved data availability and reporting to executive management
Consultant will be required but not limited to the following:
- Perform a wide variety of analytical chemical analyses for release of raw materials, intermediates and small molecule API drug substance with a proven ability in general wet chemistry and chromatography (HPLC, UPLC, GC).
- Perform instrument maintenance and troubleshoot equipment as needed
- Perform method development including instrument parameters, new instruments and method improvement studies.
- Adhere to all EPA, FDA, cGMP and DEA regulations and internal SOPs as they relate to the operation of the Quality Control lab and general operation of the chemical production facility.
- Responsible for coverage of all job duties typical for analytical method development and validation.
- Experience with Wet Chemistry, Chromatography (HPLC, UPLC, GC) -MUST, cGMP Regulation knowledge – PREFFERRED.
- Experience in small molecule environment, Extensive knowledge of analytical instrumentation – PREFERRED
Pharmaceuticals (Cell Therapy)
- Establish and develop analytical methods. Work with Quality Control and other Operations groups to trouble-shoot and improve existing analytical methods.
- Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers.
- Routine sample analysis to support process development. In summary, the responsibilities include method establishment, development and routine sample analysis to support process development and pilot production.
- The analytical methods routinely used include A280, capillary Gel Electrophoresis (cGE), capillary Isoelectric Focusing (cIEF), ELISAs, liquid chromatography (U/HPLC) and quantitative PCR (qPCR).
- Hands-on exp with A280, cGE, cIEF, ELISAs, chromatography and/or qPCR and LARGE MOLECULE is a MUST.
- Working knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment STRONGLY PREFERRED.
- Routine use of MS Excel, MS PowerPoint and MS Word is a MUST excellent writing, communication and presentation skills a MUST.
PLEASE APPLY WITH 2-3 REAL WORLD EXAMPLES OF WHERE YOU HAVE THE ABOVE EXPERIENCE!
The ability to perform as a MOST IMPORTANT ASPECT OF LISTING (please highlight this experience thoroughly)
- Under general supervision, performs primarily routine testing for chromatographic and
spectrophotometric methods of analysis in support of pharmaceutical API and/or drug product.
Testing can include but is not limited to assays (potencies, related substances, residual solvents,
metals, etc.), rate of release (dissolution), moisture, identification, and other various wet
chemistry-based measurements. HPLC, UPLC and GC based methods are commonly employed
along with titrations, UV-Vis and IR
Follows all applicable regulatory guidelines, cGMP guidelines, Environmental Health and Safety
regulations as required by the job function
- Reviews analytical data, ensures accuracy of the testing procedure by following data review
Analyzing samples from various sources to identify compounds or quantify compounds present
Using analytical techniques and instrumentation, such as gas and high-performance liquid
chromatography (HPLC), ion chromatography, electrochromatography and spectroscopy
(infrared and ultraviolet, amongst others)
- Interpreting data and adhering to strict guidelines on documentation when recording data
Developing techniques for the analyses of drug products and chemicals, reporting scientific
results, and acting as SME for analytical techniques when needed
Performs statistical analysis on analytical testing data of raw materials, finished products and lab
batches for hypothesis testing, trend analyses, specification etc.
- Review requirements specifications documents to provide timely and meaningful feedback.
Create detailed, comprehensive and well-structured test plans and test cases.
- Must have good experience working with SQL Database, Unica Campaign Tools.
- Must have Database Marketing industry experience.
- The Business Systems Analyst is responsible for designing and implementing database solutions for
- This position is responsible for acting as a liaison between Clients, the Implementation team, Analytics
and IT associates.
- The analyst captures business requirement documents and provides guidance and technical
documentation for all data processing and software solutions.
This position also reviews and analyzes database solutions and is an integral part of the project design
- It is important that the analyst guide the Client to the best solutions possible.
- Estimate, prioritize, plan, and coordinate with the team in collating the required data and solutions.
Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring
- Develop a detailed project plan to monitor and track progress, manage changes to the project scope,
project schedule and project costs using appropriate verification techniques.
The following website advertisement will be be posted from 05/24/2021 – 06/18/2021
CQV Consultant needed w/Masters degree or Foreign Equivalent in Industrial Engineering or Mechanical Engineering or Systems Engineering and one (1) year experience as CQV Consultant or Quality Engineer performing following job duties or Bachelors degree or Foreign Equivalent in Industrial Engineering or Mechanical Engineering or Systems Engineering and five (5) years of progressive work experience as CQV Consultant or Quality Engineer performing following job duties:
Draw insights from projects and supplemental research to drive new and existing growth. Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Perform corrective action and quality improvement activities. Receive inspection, calibration and MRB. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics. Perform document control, training coordination, distribution of documents and other applicable duties. Perform QMS activities – Document Control, Training coordination and CAPA and Deviation in accordance with procedures. Support updating QMS systems and perform validation as necessary. Identify and implement improvements to Quality Management System.
6 months+ – 12 months Ext
Project Overview- ARGUS HUGE +
Strong validation/CSV documentation, especially strong in creation of test scripts (Config IQs/OQs/PQs) and test execution.
Ideally prefer local candidates if available with system knowledge in Argus AE system (preferred)
Knowledge of different types of hosting – on-prem/in-house, Vendor hosted/SaaS, multi-tenant, etc. is desirable
7-8 years of CSV
ARGUS (system/workflow/business process)
Validation/ CSV documentation
creation of test scripts (Config IQs/OQs/PQs)
- Ideal candidate will be supporting the development and manufacturing of medical devices in conformance with quality system regulation, ISO 13485, MDD, ISO 14971, IEC 60601 and other Regulatory standards.
- Incumbent will ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- This person will lead all risk management activities, ensure procedures and files are maintained to State of the Art, and ensure all applicable staff are sufficiently knowledgeable and contributing to streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
- In addition, they’ll provide guidance for the application of internal development procedures, including design control, to the product development teams across all levels of the organization throughout multiple disciplines including R&D, RA, Program management, and marketing.
- DFSS, ISO 14971, Design Controls, FMEA, DFMEA, DFSS, Six Sigma Black Belt would be ideal, CQE, Reliability Engineering, Statistical Techniques, Sampling Size Justifications, Minitab, Software Validation, and working knowledge of electro-mechanical devices, software validation methods, and/or plastics related to manufacturing processes (i.e. extrusion, injection molding, RF Welding, etc.) familiarity with gage and inspection techniques. Strong collaboration, negotiation, and conflict resolution skills.
Drug Safety Specialist needed w/Masters degree or Foreign Equivalent in Pharmacology or Pharmaceutical Science or Drug Regulatory Affairs and six (6) months experience as Drug Safety Specialist or Drug Safety Associate performing following job duties:
Receive and review adverse events forms for completeness, recognize discrepancies, enter data into safety database, obtain follow-up information and assess causal relationship of event to study drug. Design and implement safety data management processes to ensure completeness, correctness and consistency of safety data. Research and provide medical and scientific information to health care professionals and functional areas within the company. Ensure delivery of quality data outputs for each data acquisition or periodic report within defined timelines. Conduct and analyze medical and scientific literature searches to support projects and queries. Perform document-tracking process for incoming documents, ICSR submission, investigator letter and CCSI distribution. Work with Clinical Resarch and Contract Research Organizations, regarding information exchange and safety exchange agreements.
NYC or client sites across the U.S.
Must be available to travel and relocate to client sites.
Analyzes and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures and provides advice on issues within the engineering field.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
Bachelor’s degree in mechanical, electrical, or mechatronics engineering from an accredited university. Four years of engineering experience with responsibility for manufacturing support, or process design. Two of the four years additionally include equipment engineering responsibilities for specifying, designing, qualifying, or troubleshooting equipment to support product/process development or manufacturing operations.
- Ability to analyze, troubleshoot and resolve issues relating to the safety, ergonomics, and efficacy of equipment, tooling, and fixtures.
- Ability to identify equipment, fixture, service, design and fabrication suppliers; assess supplier capability and recommend their use.
- Ability to specify requirements and execute factory and site acceptance testing (FAT/SAT) for custom or off-the-shelf purchased equipment.
- Ability to create equipment specifications and define requirements for the installation (IQ) and operational qualification (OQE) of equipment, tooling, and fixtures.
- Ability to perform duties in compliance with a site quality management system that is governed by the US Code of Federal Regulations, Title 21 and European MDD.
Quality Assurance Inspector needed w/Master of Pharmacy or Foreign Equivalent in Pharmacology & Toxicology or Pharmaceutical Sciences and one (1) year experience as Quality Assurance Inspector or Quality Control Officer performing following job duties:
Perform in-process and finished product inspections and document results on various packaging lines. Sample incoming raw material, packaging material and finished products. Ensure compliance with cGMP regulations. Review and approve Controlled Documents, SOP, Specification Report, art-work for Labels/Cartons and in-process batches. Responsible for timely closure of Batch Records and deviation report. Write implementation plan for change Control. Archive record for material destruction. Conduct internal audits. Write annual product review. Startup checks for manufacturing and packaging area. Change control procedure for process and material. Review record for Vendor Qualification and Material Disposition. Review completed batch production and packaging record.
- Bulk API Manufacturing
- Consultants will be required but not limited to the following:
- Perform a wide variety of analytical chemical analyses for the release of raw materials,
intermediates, and small molecule API drug substances with a proven ability in general wet
chemistry and chromatography (HPLC, UPLC, GC)
- Perform instrument maintenance and troubleshoot equipment as needed
- Perform method development including instrument parameters, new instruments, and method
- Adhere to all EPA, FDA, cGMP, and DEA regulations and internal SOPs as they relate to the
operation of the Quality Control lab and general operation of the chemical production facility.
- Responsible for coverage of all job duties typical for analytical method development and
- Experience with Wet Chemistry, Chromatography (HPLC, UPLC, GC) -MUST, cGMP Regulation
knowledge – PREFERRED
- Experience in small molecule environment, Extensive knowledge of analytical instrumentation –
- Very busy, Growing fast.
Ideal candidate will be someone that is compiling the Compliance Checklist and creating the Risk Management Files – not someone that just performs System Verification where they are merely taking the OUTPUT. This candidate will be performing the analysis and creating the risk files, creating the checklist, showing the evidence, running the tests, investigating the issues, etc. Needs to really take charge on developing and leading the team on Verification Procedure, rather than just following the guidelines and taking the output.
Candidate will be tasked with helping write test protocols, execute test protocols and documenting this work with test reports as they go. Main functions of the tests are to perform Risk Management and Product Safety for these ophthalmic medical devices. Must be fluent in the main compliance standard IEC 60601-1 for electrical safety, risk management files, and extensive documentation to ensure the products are safe to release to manufacturing.
Client needs a System Engineer to support new product development. Fast-paced R&D environment and a very recently released product that they are updating with major features, essentially a 1.5 version of a pre-existing product. This engineer will be helping with tasks on the prior generation of the product and helping with sustaining and testing tool fixtures and modules, etc. Emphasis on Test Compliance as opposed to Quality Compliance – prior candidate was very strong but was used to a much more stringent Government-regulated environment, whereas this is product development and R&D with firm deadlines.
These resources will begin by reviewing validations that have been done over the past three years and identifying gaps, focusing upon, among other things, appropriateness of sample sizes and statistical rationales. After identifying gaps and identifying remediation’s, they will rewrite the protocols, educate those performing executions on some of the problems that may arise and how to address them, then oversee the executions, gather the master data, and write the final reports.
Equipment and Process Validation a MUST
Equipment will include, but not be limited to, CNC mills, mills, asd laser marking equipment. Processes will be customer-specific molding processes, primarily injection molding a MUST.
- Perform testing to qualify raw materials vendors and assist in establishing product
- Perform laboratory equipment calibration/verification and preventative maintenance.
- Provide analytical support to Product Development, QC, QA and Regulatory departments as
- Perform troubleshooting and investigations under the direction of management.
- Perform structure elucidation of unknown impurities/degradation products when necessary.
- Communicate material issues or testing delays to the appropriate internal customer(s) (i.e.,
- Peer review of data, reports and notebooks
- Develop and validate analytical test methods for assay, impurities/degradation products,
preservatives, leachable, residual solvents in drug products according to ICH/FDA/USP
- Analyze test results, draft validation reports and make technical recommendations.
Introduce and evaluate new technologies/instrumentation and assist the department head with
the introduction of new technologies and instrumentation.
- Bachelor’s degree in Microbiology and 4 – 5 years of laboratory experience or a master’s degree
in Microbiology and 2 – 3 years of experience, preferably within a pharmaceutical or
Looking for a validation resource to support annual equipment qualification and connect PDA system to stand alone equipment. 1 example would be connecting their new autoclave to this system. This will also involve writing test scripts, protocols and checking data integrity. Consultant will aseptic validation experience and computerized system validation (21 CFR part 11)
Individuals with computer system validation experience (e.g., does their experience involve manufacturing equipment as well as laboratory equipment, software upgrades, install of new computerized systems)