Manufacturing Associate IV - Visual Inspection & Packaging

About the position

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations, and our teams operate across the following units: Visual Inspection.

Responsibilities

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks
• Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
• Be a team player and leader; always showing up to contribute your energy and focus
• Assist in investigations of procedural deviations
• Adhere to aseptic gowning and operating procedures
• Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Requirements

• Bachelor’s Degree (STEM preferred) plus at least 2 years of directly transferrable experience OR
• BioWorks Certificate or Associate’s Degree plus at least 2.5 years of directly transferrable experience OR
• High School Diploma (or equivalent) plus at least 3 years of directly transferrable experience
• Capable of working twelve (12) hour shifts in a predetermined schedule rotation
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
• Strong desire to learn and grow quickly - demonstrated experience employing learning agility
• Adaptable to changing needs and demands, comfortable navigating a dynamic environment
• Strong communication skills

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation