MCS Manufacturing Associate

Job Title:

MCS Manufacturing Associate

Job Description

The MCS Manufacturing Associate works fully onsite in a dynamic production environment, supporting development, clinical, and launch manufacturing activities. Under general supervision, this role performs hands-on operations in a cGMP-regulated manufacturing area, following Standard Operating Procedures to ensure safe, compliant, and efficient production.

Responsibilities

+ Perform hands-on manufacturing operations, including set-up, cleaning, and sanitization of a variety of production equipment.

+ Follow GMP documents, including Standard Operating Procedures (SOPs) and Manufacturing Procedures (MPs), with strict adherence to safety and compliance requirements.

+ Monitor critical manufacturing processes and perform basic troubleshooting when issues arise.

+ Conduct in-process sampling of equipment and operate analytical equipment as directed.

+ Maintain an organized, clean, and compliant workspace at all times.

+ Work in a clean room environment while wearing required personal protective equipment, including steel-toe shoes, full clean room gowning, hairnet, and gloves.

+ Initiate quality reports to document deviations, issues, or nonconformances in a timely and accurate manner.

+ Draft and revise documents such as SOPs and MPs to support continuous improvement and documentation accuracy.

+ Identify, recommend, and implement improvements to routine functions and processes to enhance efficiency and quality.

+ Assist in the review of documentation for assigned functions, including equipment logs and batch records, to ensure completeness and accuracy.

+ Perform activities that may require periods of rigorous, repetitive work on the production floor.

+ Work safely around high-pressure systems and occasionally around heavy equipment, following all safety protocols.

+ Support production needs by working various shifts, including days, swings, graves, weekends, and holidays, as dictated by the production schedule.

+ Collaborate effectively in a team environment to complete operational tasks and support shared goals.

+ Follow all documents and policies at all times, taking direction well while also demonstrating initiative.

+ Contribute to a positive work environment through professional, respectful interactions with team members.

+ Regularly lift up to 35 pounds and push or pull objects requiring up to 50 pounds of force as part of daily duties.

+ Perform physical movements required on the production floor, including bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off the ground.

Essential Skills

+ Experience working in a GMP or cGMP-regulated manufacturing environment.

+ Ability to follow GMP documents, SOPs, and MPs with strong attention to detail and compliance.

+ Capability to perform hands-on equipment set-up, cleaning, and sanitization.

+ Basic troubleshooting skills for monitoring and supporting critical manufacturing processes.

+ Ability to perform in-process sampling and operate analytical equipment as instructed.

+ Strong organizational skills to maintain a clean and orderly workspace.

+ Ability to work in a clean room environment while adhering to strict gowning and PPE requirements.

+ Comfort working around high-pressure systems and heavy equipment while following safety procedures.

+ Physical ability to regularly lift up to 35 pounds and push or pull up to 50 pounds of force.

+ Physical capability to stand for long durations and perform bending, reaching, climbing, kneeling, squatting, stooping, and stair or ladder use up to 6 feet.

+ Willingness and ability to work rotating shifts, including days, swings, graves, weekends, and holidays, based on production needs.

+ Ability to work effectively in a team, take direction, and follow established policies and procedures.

Additional

Skills & Qualifications

+ Experience drafting and revising SOPs and manufacturing documents is beneficial.

+ Experience initiating and documenting quality reports or deviations is an advantage.

+ Prior experience reviewing equipment logs and batch records is preferred.

+ Demonstrated ability to identify and implement process or workflow improvements.

+ Strong communication skills and a collaborative approach that supports a positive team culture.

+ Comfort with performing rigorous, repetitive tasks in a production environment.

Work Environment

This is a fully onsite role in a regulated manufacturing facility that operates on a rotating schedule, including day, swing, and graveyard shifts, as well as potential weekend and holiday coverage. Work hours may follow various patterns such as 5x8-hour, 4x10-hour, or 3-4x12-hour shifts, depending on production requirements. The role is primarily performed in a clean room environment with strict adherence to GMP standards and cleanliness protocols.

Team members regularly work around high-pressure systems and occasionally around heavy equipment, following defined safety…