Manufacturing Senior Associate

Job Title:

Associate Manufacturing Senior

Location:

Holly Springs, NC 27540 Duration: 12 Months Work Arrangement: 100% Onsite Work Schedule

• Rotating 12.5-hour Day Shift (5:45 AM - 6:15 PM)
• Rotation:
  Sunday/Wednesday/Thursday one week and Monday/Tuesday/Friday/Saturday the following week
• Must be flexible to work weekends and holidays as required
• Training
  
  Schedule:
  
  Monday - Friday, 8:00 AM - 5:00 PM for the first 2-6 weeks

The Associate Manufacturing will work in a dynamic production environment supporting development, clinical, and launch activities. Under general supervision, the employee will perform manufacturing operations according to Standard Operating Procedures (SOPs).

• Follow GMP documents (SOPs, MPs) with strict adherence to safety and compliance.
• Work in a cleanroom environment wearing steel-toe shoes, full cleanroom gowning, hairnet, and gloves.
• Initiate quality deviation reports.
• Draft and revise documents (SOPs, MPs).
• Assist in the review of documentation for assigned functions, including equipment logs and batch records.
• Identify, recommend, and implement improvements related to routine functions.

• Perform hands-on operations including equipment set-up, cleaning, and sanitization.
• Prepare buffers and media according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs).
• Perform and monitor critical manufacturing processes and conduct basic troubleshooting.
• Perform in-process sampling and operate analytical equipment.
• Complete washroom activities by cleaning small- and large-scale production equipment.
• Maintain an organized and clean workspace.
• Perform documentation activities.
• Set up materials and equipment.
• Run automated equipment cleaning and process steps.
• Perform sampling and sample testing.
• Perform cleaning and housekeeping of the manufacturing area.

• Perform repetitive manufacturing activities.
• Work around high-pressure systems and heavy equipment.
• Lift up to 35 lbs and push/pull up to 50 lbs
  .
• Perform bending, kneeling, squatting, stooping, climbing, reaching overhead, walking stairs, and standing on ladders up to 6 feet
  .
• Be available to work various shifts, including weekends and holidays, based on the production schedule.

• High School Diploma/GED with 4 years of work experience

• Associate Degree with 2 years of work experience

• Bachelor's Degree

• Ability to learn and independently operate complex computer and manufacturing equipment systems.
• Ability to work in a fast-paced, hands-on, rapidly changing manufacturing environment.
• Strong focus on safety, quality, and compliance.
• Ability to work effectively in a team environment.
• Ability to follow procedures and policies.
• Ability to take initiative and create a positive work environment.

• Evidence of technical skills/aptitude and ability to independently learn complex computer and equipment systems.
• Ability and desire to work in a fast-paced, hands-on manufacturing environment.
• Strong focus on safety, quality, and compliance.
• Must have safety shoes (non-prescription safety glasses will be provided).

• Perform assigned manufacturing tasks safely and compliantly.
• Set up materials and equipment.
• Run automated equipment cleanings and process steps.
• Perform sampling and sample testing.
• Complete manufacturing documentation.
• Perform cleaning and housekeeping activities based on the production schedule.

• Candidates who cannot commit to the required rotating schedule, including weekends and holidays.
• Candidates unable to maintain regular attendance (greater than 90% of assigned shifts).

• Virtual video interview with the Hiring Manager.