MCS Manufacturing Sr. Associate

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