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Pharmaceuticals   |   Biotech   |   Healthcare

careers@globalpharmatek.com

We aspire to be the Clinical Research Organizations that is a solid contributor in driving more customer projects in the market or is an important decision-maker in the whole industry. In brief, we want to be the partner of choice in the process of drug development. That is our core vision, which drives all our efforts and for that, we never cut down the need to hire more talented people and achieve that goal.

If you share our aspirations then join us today. By being a part of us, you will be able to bag the chance to work in a spectacular environment with the most intelligent and innovative team, moreover, you will be making a contribution that will help shape a better industry!

Current Openings

 

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Job Description:

Global PharmaTek, LLC has job openings for Process/Validation Engineer. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Authors engineering study protocols for the vial washer, depyrogenation tunnel, vial filler, puck washer,tray loader and filter skid associated on the Abboject and Ampoule filling lines.

Reviews standard operating procedures which are related to each equipment according to 21 CFR part 11.Uploads developed protocols in the company’s record website by following the procedures.Prepares riboflavin solution in biological quality lab by following the procedure and uses on vial washer and puck washer to test spray coverage test on filling lines.Prepares biological samples to verify the sterility of the heating and cooling zones in depyrogenation tunnel.Witnesses’ vendor SAT (Site Acceptance Test) protocol and execution of all equipment associated with each filling lines.Calculates particle count at the equipment on the Abboject and Ampoule filling lines to verify if rooms are maintaining Grade A aseptic conditions.Performs smoke studies to verify the laminar flow hoods are working consistently throughout in Grade A aseptic conditions. Executes engineering study protocols and acquires required parameters which are used to perform drug production activities.Develops summary reports on executed engineering study protocols on all equipment associated with Abboject and Ampoule filling lines.  Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH19; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Quality Systems Specialist.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Support in the implementation and maintenance of our Data Governance Team.Support implementation of data integrity controls for computer systems, laboratory and Manufacturing equipment and instruments, and processes.Conducts working sessions with subject matter experts to document processes and Identify gaps related to data integrity through Process mapping and typical maps by MS Visio.Knowledge of Quality Systems, specifically Data Integrity, CAPAs, Deviations, and Risk Assessments.Working experience in Equipment/Instrument Qualification or Computer System Qualification.Conduct internal audits and chart reviews to assist with the monitoring and tracking of data quality to improve data output.Working knowledge on various lab and manufacturing equipment.Sound Knowledge on FDA, GMP, GDP, GLP, 21 CFR part 11 guidelines and regulations.Knowledge of methods needed to conduct data integrity activities on Quality Systems and able to communicate with lab and manufacturing personnel by performing periodic training sessions as required.In order to perform the essential job functions of this position, candidate must be able to Compose/write descriptive reports; use appropriate techniques to implement programmatic activities; verbally direct individuals and groups; successfully complete mandated training courses.Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH19; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for CMC Specialist-Regulatory Affairs.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Operated as a member of the CMC Product team to, provide project management support for development and maintenance of timelines and collection of CMC deliverables related to preparation of Chemistry, Manufacturing, and Controls information for new product registrations or post-approval changes including annual reports, registration renewals, supplements, variations, commitments, tender bids and responses.Led the planning and creation of a detailed project plan in GRACS planning tool for CMC submissions with input from identified stakeholders and the CMC Product Lead. Managed project deliverables during all phases of submission preparation (e.g. authorization, assessment, execution and close-out) and ensured project tasks are completed against plan. Utilized and maintained GRACS and/or MMD systems to support compliant operational execution of activities related to change control and dossier preparation (GCM, RCAM, ORION, USPT, Red Compass, etc.), as needed.Led discussions and negotiated resolution of scheduling conflicts with MMD and Site/International CMC stakeholders to provide visibility to project constraints. Supported CMC scientists in collection of information to support change assessments and dossier strategy. Liaise with MMD and internal stakeholders to support compliant execution of change management and CMC business processes. Tracked project deliverables through appropriate business processes (Manufacturing Change Control Management, Content Authoring, Health Registration Management, and Regulatory Submission Planning). Conducted all activities with an unwavering focus on regulatory conformance. Identified, assessed, and communicated actively to resolve or escalate potential project challenges with the CMC Product Team and/or GRACS CMC management, as needed.Assisted in the development and continuous improvement of business processes, tools, systems, metrics and analytics under supervision of manager. Supported submission preparation and delivery under the direction of the CMC product lead and/or team members. Developed virtual document structures & metadata.Responsible for formatting, editing (e.g. grammar, spelling, and punctuation), finalizing and uploading submission related documentation into GRACS systems/tools (RCAM, USPT). Coordinated the flow of documents via document-sharing systems (e.g., SharePoint, RCAM Workflow) to ensure version control throughout the submission generation process (writing, review, and internal approval).Provided support for other CMC projects and activities, as required.Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH18; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Drug Safety Associate.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE’s are complete prior to database closure Process and distributes clinical study SAE reports as per the company SOPs Completes AE/SAE reconciliation prior to clinical trial database closure Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s .Processes all types of adverse event reports utilizing the ARIS safety database Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed Assists with implementing safety surveillance processes and establishing appropriate SOPs Experience.Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH17; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Document Quality Specialist. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Responsible for Generation, maintenance including follow up for documents and finalization of Trial Master File Table of Contents. Review of client documentation with respect to content, cross-section referencing and compliance with appropriate regulations. Pre-Audit/Inspection review of Trial Master File (TMF) documentation in accordance with or client company Sop’s. Troubleshooting location of documents and assign appropriate location of files. Reconciliation and remapping of TMF.Worked with multiple client filing structures.Responsible for ensuring compliance with client and Company SOP’s. Processing client documentation into company eTMF solution. Preparation of documentation for archival, in accordance with SOP’s and industry standards.Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates. Responsible for setting up, maintaining an ongoing basis, providing expertise in quality controlling and archiving of the global Trial Master File (TMF) (paper TMF or eTMF) – including but not limited to Study Files. Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers. Requires Minimum Bachelor’s Degree in Health Administration or closely related field, and relevant 1-2 years of experience

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH16; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Clinical Research Coordinator. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Work in collaboration with principal Investigator and assisting in submission of IRB Approvals, SAE Reporting, addressing and reporting protocol deviations, Track and collate clinical trial documentation related to Clinical Study Report (CSR) appendices, Review study – specific CRF and source documents, Perform Source data verification (ALCOA) of clinical data in subject binder and EDC,Addressing issues and queries of clinical team during database close (DBC) and data base lock(DBL). Identification and Control of the raw material, Drug substance and ensure chemical stability,. Perform Chemical analysis of biological specimens and evaluate the laboratory data, Resolving system generated and data management generated queries in EDC, Checking the accuracy of clinical documents and archiving data in subject binders according protocol guidelines, Facilitate improvement in overall quality and completeness of trial documentation through the query process along with formal and informal education, Review of listings and tables for accuracy and completeness, Assisting and facilitating data for the CRA during study monitoring visit. Updating patient visit reports in IVRS and dispensing study drug as per IVRS Reports, Ensure proper storage conditions for study drug and supplies and ensure quality control and quality assurance of drug substances, Perform proper storage and shipment of Bio-specimens along with tracking and updating data in EDC systems and subject binders.Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH15; EOE
Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Clinical Contract Associate.
Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Provide contract administration support in response to Contracts Records ,Management and Cleanup for GDAR, Apollo migration and CLMS,Reconcile contracts in Apollo and CMS, Review all executed clinical contracts saved on Apollo and CMS and perform reconciliation between the contracts that are saved in these two platforms, Scan and create Optical Character Recognition (OCR) via Adobe Acrobat for various executed contracts including CTAs, CDAs, LOAs, Vendor Agreements,Performing QC on the scanned contracts to ensure All pages of the documents are included, All required signatures are verified and present, All budget pages are legible, All pages have undergone OCR conversion, Documents have been saved in the Shared Folder in Apollo,Enter Agreement Party Information on Clinical Management System (CMS), Identify metadata for each contract,Upload contract(s) to CMS,Complete required metadata fields in CMS with contract party information. Requires Minimum Bachelor’s Degree in Pharmacy, Life sciences, Health science or a related field and relevant 1-2 years of experience.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH14; EOE

Location: Edison, NJ

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Job Description:

Global PharmaTek, LLC has job openings for Compliance Manager (Pharma). Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Develop innovative value propositions within the clinical research and life sciences space to meet global regulatory compliance relating to pharmaceutical, bio-pharmaceutical, and medical devices manufacturing. Provide leadership and technical decision-making for various stakeholders, management, and high-level technical personnel regarding cGMP, GCP, ICH compliance, regulatory audits, strategy, clinical, and quality systems for projects and strategic activities. Author, review, and implement SOPs to ensure compliance with current international regulatory standards and cGMP. Lead cross-functional analytical teams in the resolution of business or systems issues in pharmaceutical manufacturing. Create and develop relationships with clients and identify future opportunities. 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 Computer Science, Engineering (any), Business Administration, Life Sciences, or a related scientific/quantitative discipline.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH13; EOE

Location: Edison, NJ

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Job Description:
Global PharmaTek, LLC has job openings for Sr. Pharmacovigilance Scientist I. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation. Safety Committee preparation and documenting of meeting minutes. Review urgent safety issues and escalate to MD. Initial preparation of RMP and PV plans. Literature search terms and summary results review and escalation to MD. Responsible for clinical study such as IB and NDA, safety benefit-risk review, and ad hoc reports. Aggregate report review and input for assigned products such as PSURs, PBRER, PADER – triage to MD. Interact with vendor contracted to author aggregate reports for specific products, as needed. In collaboration with the team, contribute to and help coordinate responses to safety questions from regulatory authorities for assigned products. Contribute to initiatives for process improvement and consistency regarding aggregate reporting, signal management, and responding to ad hoc safety questions. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Public Health, Life Sciences, or related.

Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 17GPH12; EOE

Location: Edison, NJ

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Job Description:
Global PharmaTek, LLC has job openings for Sr. Validation Engineer I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. 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. 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 Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Mail resume with cover letter to Global PharmaTek, LLC, 2025 Lincoln Highway, Suite 225, Edison, NJ 08817; Job 16GPH11; EOE

Location: Edison, NJ