AM Logic Corporation has job openings for Lead Business Systems Analyst.

Location: Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Description:

• Use advanced knowledge to analyze gaps in the current system and advise on changes required to fulfill business needs of the project.
• Conduct interviews with service provider vendors to understand their system and how changes required will impact them.
• Review business requirements and deliver functional specifications document.
• Work closely with user interface web designers to create screen layouts.
• Create test plans/cases based on user/functional specifications.
• Conduct user acceptance testing to verify and ensure accurate delivery of the business needs.
• Work with various technologies such as SAP and HP ALM.
• 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), Business Administration, 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), Business Administration, 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 18AMC02; EOE

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

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 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 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

AM Logic Corporation has job openings for Sr. Validation Engineer I.

Location: Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Description:

• Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities.
• Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Create, populate, and maintain databases for tracking validation activities, test results, and validate systems.
• Work with various technologies such as SharePoint, MS Visio, and MS Excel.
• Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
• Requires Master’s degree or foreign equivalent in Healthcare Informatics, Engineering (any), Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; Job 20AMC05; EOE

AM Logic Corporation has job openings for Regulatory Affairs Specialist.

Location: Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.

Job Description:

• Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance, approval, and registration of products.
• Communicate submission requirements to product development and process improvement teams.
• Serve as an internal consultant to project teams, providing Regulatory Affairs feedback and guidance on new product development, design changes, as well as other proposed changes that may require regulatory inputs.
• Maintain annual facility registrations and product listings as appropriate.
• Develop competitive regulatory strategies and execute on filing submissions to regulatory authorities and ensure the maintenance of regulatory files.
• Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
• Requires Bachelors in Pharmacy, Regulatory Affairs, any Scientific Degree, or related.

Mail resume with cover letter to AM Logic Corporation, 3830 Park Avenue, Suite 207, Edison, NJ 08820; Job 20AMC04; EOE

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.
• 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