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
Position Summary
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).
Key Responsibilities
Compliance
- 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.
Process / Equipment / Facilities
- 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.
Physical & Operational Requirements
- 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.
Basic Qualifications
- High School Diploma/GED with 4 years of work experience
OR
- Associate Degree with 2 years of work experience
OR
Preferred Skills
- 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.
Top 3 Must-Have Skill Sets
- 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).
Day-to-Day Responsibilities
- 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.
Red Flags
- 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).
Interview Process
- Virtual video interview with the Hiring Manager.
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