Gforce Life Sciences Remote Remote Jobs Near, ME Jobs in Usa
7 positions found
Global Product Quality Specialist
12-month Contract
Responsibilities:
- Quality Systems Support:
- Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
- Support of regulatory submissions, annual reports and preparation of annual product quality reviews
- Inspection readiness for Internal and external audits
- Compile metrics for continuous improvement initiatives
- Assist in the writing of Quality Agreements
- Documentation Review:
- Review of API, DP and Packaging batch records
- Review of test methods, component specifications, validation protocols/reports, BOM
- Review of stability protocols and reports, and data in LIMS
- Operational QA Support:
- Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
- Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
- Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
- Project QA Support:
- Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
- Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply
Qualifications:
- BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
- 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
- Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
- Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
- Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
- Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
- Strong written and verbal communication skills; ability to collaborate with cross-functional teams
- Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
- Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.
Pharmacovigilance Scientist
3-month contract
Hybrid in Waltham, MA
Weβre seeking a Senior PV Scientist to support safety and risk management activities for investigational and marketed products within an oncology portfolio. This role partners closely with the Safety Physician to evaluate, interpret, and communicate product safety data while ensuring compliance with global regulations.
Key Responsibilities:
- Lead safety analytics and signal management for assigned products
- Author and coordinate aggregate safety reports (DSURs, PSURs, PADERs)
- Review and contribute to clinical and regulatory documents (protocols, IBs, CRFs, ICFs)
- Manage safety queries, data analyses, and health hazard evaluations
- Collaborate cross-functionally with Safety, Biostatistics, Clinical, and Regulatory teams
- Support process improvement initiatives and ensure compliance with PV standards
Qualifications:
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP, or equivalent)
- 5+ years of relevant medical, scientific, or pharmaceutical experience, including 3+ years in pharmacovigilance or drug safety
- Must have experience in mental health or neurology
- Strong analytical, communication, and project management skills
- Proficiency in Excel, PowerPoint, and safety database systems (e.g., Argus)
Laboratory Operations Specialist
6-month Contract
Hybrid in Novato, CA
Must be able to work on a W2
The Senior Specialist, Laboratory Operations, coordinates and supports multiple laboratories within one or more departments. This could include ownership/responsibilities over any associated warehouse areas, performing glassware washing and media/buffer prep.
- Experienced and works independently to manage day-to-day operations and can perform troubleshooting and problem solving. Customer base is within the labs supported. Highly customer service oriented and has a track record of anticipating the needs of all customers, including bench scientists
- Responsible for cross-functional execution of processes such as equipment installation working with engineering, facilities, suppliers and procurement. Oversees inventory management such as purchasing, maintaining, storing, and allocating lab equipment and supplies.
- Can provide direction to peers, if needed. Completes assignments in a timely fashion and helps manager with assignments or projects when needed.
- Ability to work on issues with a complex and diverse scope in a matrixed organization.
- Can perform troubleshooting and basic problem-solving. Can effectively reach a solution for most problems. Proposes process improvements.
Senior Administrative Assistant
6-Month Contract
Hybrid (as needed) in San Rafael, CA (approximately 5 days/month onsite)
Must be able to work on a W2
Requirements
- Provide primary administrative support to the Head of Global Pharmacovigilance and the broader Global Patient Safety (GPS) team.
- Serve as a central point of contact, facilitating communication and supporting operational and project-based activities across departments.
- Proactively schedule and coordinate meetings and conference calls, including calendar management, room reservations, technical setup, catering coordination, preparation of materials, and recording of meeting minutes as needed.
- Anticipate and resolve scheduling conflicts to ensure productive and well-attended meetings.
- Oversee logistics for offsite meetings and team events, including hotel and restaurant bookings, catering arrangements, and team-building activities.
- Arrange business travel in accordance with company policy, managing flight, accommodation, and transportation bookings while adhering to budgetary and compliance requirements.
- Prepare and process expense reports accurately and promptly using systems such as Concur, ensuring complete documentation and timely reimbursement.
- Monitor and replenish departmental office supplies to support daily operations.
- Act as liaison for IT-related issues, facilitating timely resolution to support team productivity.
- Actively participate in on-site and off-site team meetings to support communication and operational continuity.
- Maintain and coordinate calendars for department leadership and team members.
- Submit and track departmental contract requests within the contract management system, ensuring accurate status monitoring.
- Monitor and reconcile departmental invoices to ensure financial accuracy and timely payment.
- Develop and maintain project trackers and spreadsheets, follow up on deliverables, and support status reporting.
- Organize and maintain departmental files within the document management system to ensure accessibility and preservation of institutional knowledge.
- Update and maintain departmental contact lists and organizational charts.
- Manage multiple priorities in a fast-paced, deadline-driven environment with strong attention to detail.
- Utilize Microsoft Office Suite, Concur, SharePoint, and other business tools to support efficient workflow.
- Communicate effectively with internal and external stakeholders, demonstrating professionalism, discretion, and sound judgment.
- Work independently, quickly learn new tasks, and proactively anticipate departmental needs.
Qualifications
- Minimum of 5 years of administrative experience within the biotechnology or pharmaceutical industries.
- Experience supporting pharmacovigilance functions highly desirable.
- Bachelorβs degree highly preferred.
Summary
Our client, a Fortune 500 pharmaceutical company, has engaged GForce Life Sciences to provide a Senior Electrical Engineer. the Professional Engineer (PE) will have expertise in electrical systems including electrical distributed power generation, feeds, distribution, lighting, fire alarm, emergency power, UPS, and low voltage systems. The PE is responsible for overseeing the engineering of these systems for major capital projects and initiatives from conceptualization through programming, design, bidding, construction, commissioning, and close out.
The PE will be responsible for multiple high-complexity projects of diverse scope that require an understanding of state of the art construction techniques and a high level of expertise in electrical systems, as well as rigor in compliance, and the highest standard of care. Science projects include research laboratories, vivarium, pilot scale manufacturing, major scientific equipment, amenity space, outdoor plaza, site lighting, and infrastructure projects.
The PE shall collaborate with the project team to effectively identify innovative solutions and bring clarity to the project process using a sophisticated analytical approach and sound judgement. Core focus areas include defining and meeting project goals for electrical systems, reviewing budgets, schedules, scopes, and quality, as well as risk mitigation and responding to field conditions and construction logistics and challenges.
The PE will be responsible to lead design teams and Construction Managers in both the pre-construction due diligence, design and scoping process with a focus on quality management, project controls, and user engagement as well as leading their teams through the bidding and construction administration process with a focus on field coordination, commissioning, substantial completion and close out.
Responsibilities
- Assists the Project Management team in developing the budget and schedule for design and construction projects, including renovations and green field projects.
- Works closely with Project Management, Engineering, Space Planning, EHS, Operations, and User teams to fully and rigorously document the electrical system requirements in the Ownerβs Project Requirements document.
- Performs preliminary due diligence explorations of existing electrical systems during project initiation to identify any potential risks to the project and any opportunities for improving the building systems of existing buildings.
- Assists the Project Manager and Procurement in the development of scopes of work for design professionals, construction managers, general contractors and commissioning agent RFPs. Assist in the evaluation and bid leveling of proposals.
- Participates in regular project meetings.
- Works directly with hired MEP engineers, consultants, and contractors to answer questions, resolve issues and develop solutions.
- Provides supervision for all stages of the development and documentation of electrical requirements for lab and other equipment for the project. Collaborates with the Project Management team, internal engineers, end users, the Asset Management team, EHS, design professionals, lab equipment vendors, design professionals and contractors to ensure that all electrical system requirements for the equipment are met.
- Provides detailed reviews of and comments on due diligence reports, test fits, Basis of Design documents, room data sheets, construction documents and specifications prepared by the design professionals, checking for thoroughness, accuracy and compliance with the project requirements, design and documentation standards and minimize errors and omissions.
- Identifies long lead time equipment for potential Early Works purchasing by the contractor
- Works with the Project Managers, Design Professionals and Contractors to find solutions to mitigate costs and schedule delays due to errors and omissions in the design documents and unforeseeable field conditions
- Reviews shop drawings and submittals, RFI responses, and Change Orders
- Makes frequent site visits to ensure that electrical requirements are being implemented correctly during construction and creates field reports.
- Reviews Design Professional punch lists.
- Manages commissioning, auditing, & validating facilities systems for Capital Projects.
- Assists the Asset Management and Operations team in preparing equipment lists for import into the Integrated Workplace Management System
- Coaches and Mentors other members of engineering staff and supervises day to day operation of electrical systems.
- Interacts with municipalities and Con-Ed to obtain building permits and inspections.
- Supervises, coordinates, and schedules work with outside contractors and internal technicians.
- Audits, tests, commissions, and validates Facilities systems and also provide specialized engineering support services to RGC, PMPD, PCD, IT, & Vivarium groups.
Requirements
- Bachelorβs degree in Engineering required
- Minimum of 5 years in an electrical engineering role
- In depth knowledge and extensive experience in electrical systems for complex life science laboratory and vivarium projects
- Skilled in the use of AutoCAD, Revit, Navisworks, SharePoint and Bluebeam Revu
- IWMS system experience
Terms & Start
- Onsite 4 days/week in Tarrytown, NY
- Full-time
- Start ASAP
- Benefits included (Medical, Dental, Vision)
- 27 days PTO
Summary
Our client, a Fortune 500 pharmaceutical company, has engaged GForce Life Sciences to provide a Senior Electrical Engineering Manager. The Electrical PM will have expertise in electrical systems including electrical distributed power generation, feeds, distribution, lighting, fire alarm, emergency power, UPS, and low voltage systems. The PE is responsible for overseeing the engineering of these systems for major capital projects and initiatives from conceptualization through programming, design, bidding, construction, commissioning, and close out.
The Electrical PM will be responsible for multiple high-complexity projects of diverse scope that require an understanding of state of the art construction techniques and a high level of expertise in electrical systems, as well as rigor in compliance, and the highest standard of care. Science projects include research laboratories, vivarium, pilot scale manufacturing, major scientific equipment, amenity space, outdoor plaza, site lighting, and infrastructure projects.
The Electrical PM shall collaborate with the project team to effectively identify innovative solutions and bring clarity to the project process using a sophisticated analytical approach and sound judgement. Core focus areas include defining and meeting project goals for electrical systems, reviewing budgets, schedules, scopes, and quality, as well as risk mitigation and responding to field conditions and construction logistics and challenges.
The Electrical PM will be responsible to lead design teams and Construction Managers in both the pre-construction due diligence, design and scoping process with a focus on quality management, project controls, and user engagement as well as leading their teams through the bidding and construction administration process with a focus on field coordination, commissioning, substantial completion and close out.
Responsibilities
- Assists the Project Management team in developing the budget and schedule for design and construction projects, including renovations and green field projects.
- Works closely with Project Management, Engineering, Space Planning, EHS, Operations, and User teams to fully and rigorously document the electrical system requirements in the Ownerβs Project Requirements document.
- Performs preliminary due diligence explorations of existing electrical systems during project initiation to identify any potential risks to the project and any opportunities for improving the building systems of existing buildings.
- Assists the Project Manager and Procurement in the development of scopes of work for design professionals, construction managers, general contractors and commissioning agent RFPs. Assist in the evaluation and bid leveling of proposals.
- Participates in regular project meetings.
- Works directly with hired MEP engineers, consultants, and contractors to answer questions, resolve issues and develop solutions.
- Provides supervision for all stages of the development and documentation of electrical requirements for lab and other equipment for the project. Collaborates with the Project Management team, internal engineers, end users, the Asset Management team, EHS, design professionals, lab equipment vendors, design professionals and contractors to ensure that all electrical system requirements for the equipment are met.
- Provides detailed reviews of and comments on due diligence reports, test fits, Basis of Design documents, room data sheets, construction documents and specifications prepared by the design professionals, checking for thoroughness, accuracy and compliance with the project requirements, design and documentation standards and minimize errors and omissions.
- Identifies long lead time equipment for potential Early Works purchasing by the contractor
- Works with the Project Managers, Design Professionals and Contractors to find solutions to mitigate costs and schedule delays due to errors and omissions in the design documents and unforeseeable field conditions
- Reviews shop drawings and submittals, RFI responses, and Change Orders
- Makes frequent site visits to ensure that electrical requirements are being implemented correctly during construction and creates field reports.
- Reviews Design Professional punch lists.
- Manages commissioning, auditing, & validating facilities systems for Capital Projects.
- Assists the Asset Management and Operations team in preparing equipment lists for import into the Integrated Workplace Management System
- Coaches and Mentors other members of engineering staff and supervises day to day operation of electrical systems.
- Interacts with municipalities and Con-Ed to obtain building permits and inspections.
- Supervises, coordinates, and schedules work with outside contractors and internal technicians.
- Audits, tests, commissions, and validates Facilities systems and also provide specialized engineering support services to RGC, PMPD, PCD, IT, & Vivarium groups.
Requirements
- Bachelorβs degree in Engineering required
- Minimum of 5 years in an electrical engineering role
- In depth knowledge and extensive experience in electrical systems for complex life science laboratory and vivarium projects
- Skilled in the use of AutoCAD, Revit, Navisworks, SharePoint and Bluebeam Revu
- IWMS system experience
Terms & Start
- Onsite 4 days/week in Tarrytown, NY
- 12+ month contract
- Start ASAP
- Benefits included (Medical, Dental, Vision)
Summary
Our client, a Fortune 500 pharmaceutical company, has engaged GForce Life Sciences to provide a Senior Electrical Engineering Manager. The Electrical PM will have expertise in electrical systems including electrical distributed power generation, feeds, distribution, lighting, fire alarm, emergency power, UPS, and low voltage systems. The PE is responsible for overseeing the engineering of these systems for major capital projects and initiatives from conceptualization through programming, design, bidding, construction, commissioning, and close out.
The Electrical PM will be responsible for multiple high-complexity projects of diverse scope that require an understanding of state of the art construction techniques and a high level of expertise in electrical systems, as well as rigor in compliance, and the highest standard of care. Science projects include research laboratories, vivarium, pilot scale manufacturing, major scientific equipment, amenity space, outdoor plaza, site lighting, and infrastructure projects.
The Electrical PM shall collaborate with the project team to effectively identify innovative solutions and bring clarity to the project process using a sophisticated analytical approach and sound judgement. Core focus areas include defining and meeting project goals for electrical systems, reviewing budgets, schedules, scopes, and quality, as well as risk mitigation and responding to field conditions and construction logistics and challenges.
The Electrical PM will be responsible to lead design teams and Construction Managers in both the pre-construction due diligence, design and scoping process with a focus on quality management, project controls, and user engagement as well as leading their teams through the bidding and construction administration process with a focus on field coordination, commissioning, substantial completion and close out.
Responsibilities
- Assists the Project Management team in developing the budget and schedule for design and construction projects, including renovations and green field projects.
- Works closely with Project Management, Engineering, Space Planning, EHS, Operations, and User teams to fully and rigorously document the electrical system requirements in the Ownerβs Project Requirements document.
- Performs preliminary due diligence explorations of existing electrical systems during project initiation to identify any potential risks to the project and any opportunities for improving the building systems of existing buildings.
- Assists the Project Manager and Procurement in the development of scopes of work for design professionals, construction managers, general contractors and commissioning agent RFPs. Assist in the evaluation and bid leveling of proposals.
- Participates in regular project meetings.
- Works directly with hired MEP engineers, consultants, and contractors to answer questions, resolve issues and develop solutions.
- Provides supervision for all stages of the development and documentation of electrical requirements for lab and other equipment for the project. Collaborates with the Project Management team, internal engineers, end users, the Asset Management team, EHS, design professionals, lab equipment vendors, design professionals and contractors to ensure that all electrical system requirements for the equipment are met.
- Provides detailed reviews of and comments on due diligence reports, test fits, Basis of Design documents, room data sheets, construction documents and specifications prepared by the design professionals, checking for thoroughness, accuracy and compliance with the project requirements, design and documentation standards and minimize errors and omissions.
- Identifies long lead time equipment for potential Early Works purchasing by the contractor
- Works with the Project Managers, Design Professionals and Contractors to find solutions to mitigate costs and schedule delays due to errors and omissions in the design documents and unforeseeable field conditions
- Reviews shop drawings and submittals, RFI responses, and Change Orders
- Makes frequent site visits to ensure that electrical requirements are being implemented correctly during construction and creates field reports.
- Reviews Design Professional punch lists.
- Manages commissioning, auditing, & validating facilities systems for Capital Projects.
- Assists the Asset Management and Operations team in preparing equipment lists for import into the Integrated Workplace Management System
- Coaches and Mentors other members of engineering staff and supervises day to day operation of electrical systems.
- Interacts with municipalities and Con-Ed to obtain building permits and inspections.
- Supervises, coordinates, and schedules work with outside contractors and internal technicians.
- Audits, tests, commissions, and validates Facilities systems and also provide specialized engineering support services to RGC, PMPD, PCD, IT, & Vivarium groups.
Requirements
- Bachelorβs degree in Engineering required
- Minimum of 5 years in an electrical engineering role
- In depth knowledge and extensive experience in electrical systems for complex life science laboratory and vivarium projects
- Skilled in the use of AutoCAD, Revit, Navisworks, SharePoint and Bluebeam Revu
- IWMS system experience
Terms & Start
- Onsite 4 days/week in Tarrytown, NY
- 12+ month contract
- Start ASAP
- Benefits included (Medical, Dental, Vision)