Skip to main content

Leader Regulatory Affairs CMC (drug substance)

posted by: spj_bot

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a CMC Regulatory Consultant specializing in drug substance lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The Regulatory CMC Department is looking for a senior consultant with drug substance development experience, he/she will mainly be responsible for leading the regulatory strategy.

Main Responsibilities:

Job Skills

View the job post & apply

QMS Support Manager

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a QMS Support Manager, you will support a strategic site transformation project by ensuring the successful integration of quality management systems and documentation processes following the transfer of activities to the Gidy site. You will play a key role in document harmonization, training, quality oversight, and change management while ensuring compliance with GMP requirements and project timelines.

Key responsibilities :

  • Quality management of new business requirements
  • Implementation of defined processes and support to requestors
  • Supplier monitoring and follow-up
  • Management of quality events related to supplier management: Change Controls, deviations related to the process, including compliance with timelines, supplier notifications, supplier complaints
  • Management of process-related documentation
  • Participation in continuous process improvement initiatives
  • Contribution to QMS (Quality Management System) department activities
  • Participation in inspections and audits, including the management of action plans
  • Support to business functions in monitoring and adhering to the process

Requirements

Job Skills

View the job post & apply

QMS Quality Manager

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.

As a QMS Quality Manager, you will support a strategic site transformation project by ensuring the successful integration of quality management systems and documentation processes following the transfer of activities to the Gidy site. You will play a key role in document harmonization, training, quality oversight, and change management while ensuring compliance with GMP requirements and project timelines.

Job Skills

View the job post & apply

HRIS/Payroll Administrator

posted by: spj_bot

We are seeking a detail-oriented and dedicated HRIS/Payroll Administrator to join our Human Resources team. This role is responsible for maintaining and optimizing our Human Resource Information System (HRIS) while managing payroll processes to ensure accuracy and compliance with relevant laws and regulations. The ideal candidate will have a strong background in HRIS management, payroll administration, and an analytical mindset that supports effective data management and reporting.

Key Responsibilities:

HRIS Administration:

 

·         Manage the HRIS system, including configuration, updates, and maintenance.

·         Perform regular audits of HRIS data to ensure accuracy and integrity.

·         Serve as the primary point of contact for HRIS-related inquiries and troubleshooting.

·         Collaborate with IT and vendors to resolve technical issues related to the HRIS.

·         Train and support HR staff and end-users on HRIS functionalities and best practices.

·         Maintain detailed documentation of payroll, commission and HR processes

 

Payroll Management:

 

·         Process bi-weekly payroll ensuring compliance with federal, state, and local regulations.

·         Collect, calculate, and input payroll data such as employee hours, deductions, and bonuses into the HRIS.

Job Skills

View the job post & apply

Laboratory Technician - Closing Shift- 1323

posted by: spj_bot

Under direct supervision, will be responsible for performing pre-analytical and assisting with the analytical procedures for patient testing.

REQUIREMENTS

Bachelor Degree in a Hard Scientific Field

1+ Years of experience in a professional laboratory

JOB LOCATION

Rancho Bernardo, CA

WORK SCHEDULE

  • 5 days a week, Tuesday thru Saturday - 8 hours per day
  • Shift time is 4:00 pm to 12:30 am
  • 10% Shift differential on hours worked between 9pm and 4am
  • $200.00 weekend differential when hours are worked on Saturday and Sunday

ESSENTIAL FUNCTIONS

The following are intended to be examples of the accountabilities for which the person in this position is responsible. This position is not intended to be complete or all-inclusive and does not preclude management from assigning other or related functions for which the individual has demonstrated competency through performance.

Laboratory

Job Skills

View the job post & apply

Operations Support Specialist

posted by: spj_bot

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Virgina Verified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team! We are also certified as Great Place to Work with a 97% employee satisfaction.

FirstDiv is seeking a highly motivated and detail-oriented Operations Support Specialist Level to provide comprehensive operations and program management support to the Joint Product Manager for CBRN Dismounted Reconnaissance Systems (JPdM CDMA). The Operations Support Specialist will support coordination, planning, documentation, task tracking, and operational execution for a wide array of CBRN detection and integration programs within JPM CBRN Sensors.

Key Responsibilities:

Job Skills

color executive summaries management report small business robotic support services drs functional program management acquisition work environment STD unmanned systems integration systems operations reconnaissance coordinating annual report management system read operational reporting disability document management survivability coordinate light traffic manage portfolio management microsoft office reach cross functional plan operational coordination applicable state draft field service secret clearance employee satisfaction CBRN operation management government writing track leadership process improvement management control disabled managing integration product manager internal communication logistics life insurance decision support disabilities e business program management federal law tracking policy development computer terminal communication organization integrated training compliance operating planning information management meeting minutes operate schedules detail orient operations support analytical skill procurement work order consulting public affair plans
View the job post & apply

Document Controller

posted by: spj_bot

Image removed.

Join DOF as a Document Controller!

We are looking for several experienced Document Controllers to strengthen and further develop our team and contribute to our success.

As a Document Controller you will play a crucial role in ensuring efficient document control and information management within our Atlantic region. Reporting to our Lead Document Controller in Norway, you will collaborate closely with the Project Manager and Project Technical Managers within the region.

In this role some of your main responsibilities will be to assist the Lead Document Controller in managing and supporting the Document Control requirements in the Atlantic Region. You will use different systems such as ProArc and Unisea, as well as providing training for new users in these. Analyzing the client’s requirements to execute the project and organize activities in line with project administrative requirements will also be an important part of your job.

Job Skills

View the job post & apply

Business Analyst - Gestion Documentaire Pharma

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers a great opportunity to contribute to a strategic EDMS transformation program within a global Quality environment. You will play a key role in analyzing complex data landscapes, supporting data-driven decision-making, and shaping the document migration strategy, while working in a highly collaborative and intellectually stimulating environment.

Key responsibiliities :

Job Skills

View the job post & apply

Back Office Administrator

posted by: spj_bot

Antipollution, a member of Vasileiadis Group of Companies (V Group), is a leading provider of environmental and waste management solutions across the Eastern Mediterranean, Egypt, and the Balkans. Operating in six main business pillars, including Port Reception Facilities, Emergency Response Services, Decontamination Services, Renewable Energy, Alternative Fuel Production from Waste, and Technology, we are committed to sustainability, innovation, and operational excellence.

As part of our growing operations, we are looking for a highly organized and reliable Back Office Administrator to join our team at the Ritsona Plant facility. The successful candidate will report to the Plant Manager and will support the facility and staff with all day-to-day administrative operations. The role involves accurate handling of documentation, maintaining filing systems, and ensuring effective communication with internal departments to support smooth and compliant operations.

Role Overview:

Job Skills

filing systems professional cross functional coordination business administration digital records invoice processing managing waste management administrative support organizational skill decontamination internal communication communication management schedules working environment sustainability financial datum operational archiving remuneration manager coordination internal documentation operational excellence career development teamwork medical insurance office suite reconciliation advised reliable support operations operations office administrator innovation schedule general administrative friendly alternative fuel scheme data entry emergency response document management filing data systems ERP renewable energy emergency services english written operating coordinate accounting plant operations
View the job post & apply

Supervisor, Analytical Laboratory-1660

posted by: spj_bot

Millennium Health LLC is an accredited specialty laboratory with more than a decade of experience in medication monitoring and drug testing services, helping clinicians monitor the use and misuse of prescription medications and illicit drugs. The testing is used by healthcare professionals to obtain objective information about patients’ recent use of prescription medications and/or illicit drugs and helps monitor the effectiveness of treatment plans.

WORK SCHEDULE: Tuesday through Saturday

GENERAL SUMMARY

The Supervisor, Analytical Laboratory is responsible for oversight and management of performance for the analytical laboratory processes using immunoassay and/or LC-MS/MS technology.

The following are intended to be examples of the accountabilities for which the person in this position is responsible. This position description is not intended to be complete or all-inclusive and does not preclude management from assigning other or related functions for which the individual has demonstrated competency through performance.

Job Skills

color electronic test performance operation process improvement com hipaa performing testing management supervision preventative maintenance prescription medications test systems troubleshooting writes laboratory equipment immunoassay license clinical laboratory health care www biological scheduling test method analytical healthcare professionals studies designed calibrations analytic performance specifications manage projects applicable state test communicate millennium medical technologists standard operating procedure reporting test schedule health services technical designed clinical laboratory science laboratory test continuing education read remedial action federal regulations instruments consultation quality assurance disability document management laboratory technicians validations validate corrective action e treatment plans chemical physical laboratory testing audits
View the job post & apply
Subscribe to document management

SPJ is not just a platform; it's a transformative force in the maritime sector. We reinvent job discovery and collaboration, leveraging cutting-edge AI to create a space where careers thrive and innovations set sail.

Featured Posts