AM Logic Corporation preloader

Careers

Connecting Talent and Opportunities

Careers

LOOKING FOR A JOB! Please send your resumes to careers@amlogiccorp.com

We are currently hiring: IT Services

  • Sr Systems Engineer
    • Location: Edison NJ & Various Unanticipated Locations Throughout The U.S.

      Job Description:

      • Analyzing and Debugging the code, providing support to the users of the application and handling production issues during process breakdowns.
      • Supporting tools and framework for various departments and help developers make use of the platform effectively.
      • Point of contact to Onshore/Offshore team and application users.
      • Developing JIL definitions for scheduled autosys jobs and stored procedures, Java classes which are invoked by autosys processes.
      • Responsible for the bug fixes and enhancements for Core-Web application using JAVA/J2EE.
      • Involved in developing modules and enhancements for the project implemented in Spring framework.
      • Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
      • Requires US Bachelor’s degree or it’s equivalent in Computer Science or related.

      Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; EOE



  • Lead Programmer Analyst
    • Location: Edison NJ & Various Unanticipated Locations Throughout The U.S.

      Job Description:

      • Design, develop, analyze, and test software/systems according to user requirements.
      • Customize existing software programs to meet user needs.
      • Evaluate user requests and implement accordingly.
      • Prepare instructions and logical steps for software/systems.
      • Deploy configurations changes, customization, interfaces, and data conversions throughout implementation.
      • Work with various technologies such as VBScript and SCCM.
      • Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
      • Requires Bachelor’s degree or foreign equivalent in Computer Science, Engineering (any), or related and 5 years of experience in the job offered or as a Computer Software Professional.
      • Will also accept Master’s degree or foreign equivalent in Computer Science, Engineering (any), or related and 3 years of experience in the job offered or as a Computer Software Professional.

      Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; Job 17AMC01; EOE



We are currently hiring: Healthcare Life Sciences

  • Regulatory Affairs Specialist
    • Location: Edison NJ & Various Unanticipated Locations throughout The U.S.

      Job Description:

      • Independently execute activities related to maintaining compliant Regulatory status for marketed products portfolio including annual reporting, change control management, Supplement filing (CBE-30, CBE-0, PAS), response to deficiency letters, and compliance gap closures.
      • Prepare, author, review, coordinate and manage CMC regulatory submissions, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance.
      • Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as Lifecycle management projects such as site transfers.
      • Effectively manage the preparation of CMC regulatory submission documents, including for clinical trial applications, marketing applications, post-market changes, and scientific advice in adherence with applicable regulations and guidelines for submission to health authorities.
      • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Provide Technical Guidance to the development and implementation of clinical, pre-clinical and CMC regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial)
      • Perform project management on larger submission projects (new NDAs, INDs, NDSs, CTAs, supplements, etc.) by developing and maintaining detailed submission timelines, incumbent will translate the regulatory strategy into realistic and executable regulatory deliverables with clear assumptions.
      • Review of the dossier to identify potential GAP and coordinate with Cross Functional teams to close the identified GAPs and identify the CMC data requirements for the Immunogenicity assessment of the complex drug products.
      • Compile and complete high quality ANDAs and Amendments ensuring final submission meet requirements of ANDA checklist recommended by USFSDA to avoid any acceptance to file issues. Ensure all submissions and projects are completed with the expected timeline. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
      • Managing Regulatory Information Management (RIM) process for tracking Drug Product Registrations Worldwide, including Registration Status, Variations, Health Authority Correspondences, and Commitments.

      KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

      • Masters’ degree in Regulatory Affairs/ Pharmaceutical Science
      • Special knowledge or skills needed and/or licenses or certificates required.
      • Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
      • Good working knowledge of the FDA, EMEA and ICH regulations and guidance's for CMC.
      • Knowledge of global regulatory guidance's as they relate to the overall global regulatory strategy.
      • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
      • Thorough knowledge of the drug development process, with a focus on the regulatory CMC processes.
      • Demonstrated experience in preparing IND and/or NDA submissions.
      • Proficiency with Microsoft Office, Veeva Vault, eCTD Manager, Trackwise and other EDMS systems.
      • Excellent verbal and written communication and skills.
      • Ability to work collaboratively under supervision, in a fast-paced, matrixed, team environment consisting of internal and external team members.
      • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
      • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

      Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; Job 17AMC01; EOE



  • Validation Engineer
    • Location: Edison NJ & Various Unanticipated Locations Throughout The U.S.

      Job Description:

      • Perform validation activities for the processes, facilities, utilities, manufacturing and laboratory equipment in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
      • Determine impact on product quality by analyzing the excursions identified during HEPA filter certifications and reviewing the data from biological quality.
      • Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, and packaging line equipment.
      • Perform periodic reviews and requalification on manufacturing and laboratory equipment including but not limited to vial packaging equipment, Lyophilizers, Titrating systems, Fill lines, Stopper and Capping equipment, Washers and Vision Systems to ensure that all the equipment is operating as expected and is used in compliance with industry standards.
      • Provide oversight, manage and coordinate various vendor activities including Installation and Operation (IOQ) qualifications, Vendor audits & amp reports.
      • Author Validation and Production environment computer system User & amp; Functional requirements, Validation Plan, Data Migration Plan, IQ/OQ protocols, UAT test scripts, Summary reports, Configuration Memos.
      • Develop test strategies and support computer system validation projects subject to health authority electronic record and signature requirements, including FDA’s 21 CFR Part 11 and EMA’s Annex 11.
      • Review and develop justification for the proposed changes to the qualified/validated systems, identify the qualification/validation requirements necessary to maintain the validated status.
      • Authorize, review and manage the validation final reports for multiple projects that involve qualification of laboratory and manufacturing equipment, processes, utilities and facilities.
      • Write and execute formal test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
      • Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets client’s standards, GMP and FDA regulations.
      • Perform design review to ensure the equipment is installed and operates according to the user requirement specification.
      • Should be able to use scientific and analytical knowledge to analyze data.

      EDUCATION/TRAINING:

      • Bachelor’s Degree in Pharmaceutical Science, or equivalent work experience.
      • 2+ experience in Quality, Process, Validation, Tech Service, and /or Testing.
      • Possess a working knowledge of pharmaceuticals manufacturing of solid and liquid products, or related field.
      • Preferred -Working knowledge and experience in cleaning validation and current validation trends and processes desired.
      • Experience in maintaining, follow up and implementation of CAPA system desired.

      Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; EOE



Send your Resume to careers@amlogiccorp.com


 

Call: +1 732 334 0880
Fax: (+1) 732 523 4656

Email: info@amlogiccorp.com
Web: www.amlogiccorp.com

Location: AM Logic Corporation
3830 Park Avenue, Suite # 207
Edison, NJ – 08820, USA