Job Title:

Associate of Manufacturing Duration:

6 months

Location:

Fully Onsite Schedule:

Rotating 2-2-3 (5:45 AM - 6:15 PM), 12-hour shifts

Position Overview:

The Associate of Manufacturing will work in a dynamic production environment at the client Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

Compliance:

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
• Assure proper gowning and aseptic techniques are always followed

Process/Equipment/Facilities:

• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
• Run and monitor critical process tasks per assigned procedures
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
• Perform documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space
• Ability to take initiative. Create a positive work environment through interactions with team members.
• Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations.
• Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.

Basic Qualifications:

High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree Top 3

Must Have Skill Sets:

• Ability to follow instructions and SOP's.
• Able to work assigned shift.
• Learning agility.

Possible Extension:

Yes Red Flags:

If they do not have any experience in a regulated industry such as the food industry.

Interview Process:

Virtual