MCS Manufacturing Sr. Associate

3 days ago

Thousand Oaks, United States BioPharma Consulting JAD Group Full time
Job DescriptionJob Description

Summary:
At BioPharma Consulting JAD Group, we are seeking a motivated MCS Manufacturing Sr. Associate to join our Team. As a Senior Associate, you will be supporting New Product Introduction (NPI) initiatives within the clinical and commercial manufacturing facility. If you have a strong background in project management, change control, and continuous improvement, and are dedicated to delivering operational excellence with a focus on quality, safety, and compliance, then this role is for you

Responsibilities:

  • Manage Change Control processes, ensuring comprehensive and compliant records in accordance with GMP regulations.
  • Lead diverse projects with strong project management skills, ensuring timely closure of change control records.
  • Act as the primary contact for incoming Technology Transfers and New Product Introductions into Building 20 Manufacturing.
  • Using project management tools and methodologies to plan, monitor, and report on project progress and outcomes.
  • Identify and implement improvement opportunities, fostering consensus across departments.
  • Communicate effectively with stakeholders at all levels, presenting records and business processes to auditors and inspectors.
  • Lead or participate in Continuous Improvement Transformation activities to enhance operational efficiencies.
  • Uphold safety and compliance standards at all times.
  • Leading and executing Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs).
  • Supporting the day-to-day operational needs of the facility.
  • Working in a highly collaborative team environment, interacting with Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
  • Effectively communicating with internal and external partners, including quality, engineering, validation, regulatory, and suppliers.

Skills and Attributes:

  • Strong project management skills with prior project experience.
  • Ability to work independently and collaboratively with a high level of initiative and accountability.
  • Excellent verbal and written communication skills, with attention to detail and accuracy.
  • Strong analytical, problem-solving, and decision-making skills.

Requirements

Qualifications:

Basic Qualifications:

  • Master’s degree and 2 years of Manufacturing or Operations experience, OR
  • Bachelor’s degree and 3 years of Manufacturing or Operations experience, OR
  • Associate’s degree and 6 years of Manufacturing or Operations experience, OR
  • High school diploma / GED and 8 years of Manufacturing or Operations experience.


Shift:

  • 8-hour shifts, 5 days a week

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