Manufacturing Specialist
GSK
5 hours ago
On-site
King of Prussia, PA
Operations
Responsibilities:
- Demonstrate GSK values and expectations (Patient Focus/Transparency/Respect/Integrity; Courage/Accountability/Development/Teamwork) in all interactions.
- Engage in cross-functional teams to prioritize improvements that simplify technical and business systems.
- Serve as a technical expert: understand production equipment/electronic systems and P&IDs; support quality processes (deviation, CAPA, change control).
- Own interactions between production and other departments to align needs with the manufacturing schedule.
- Follow safety procedures/training and escalate safety/compliance risks.
- Follow ALCOA principles for documentation; own deviation investigations, CAPA, impact assessments, and change controls; support auditor interactions.
- Schedule/track activities impacting manufacturing and documentation; manage raw materials/single-use component inventory; revise batch documents; use ERP; act as Lead Investigator.
- For NPI campaigns: train on and perform GMP operations (aseptic processing, cell culture, media/buffer prep, equipment prep, purification, final fill) and coach operators; may spend up to 80% in the production suite during campaigns.
- Identify/implement processing and quality system improvements and required documentation updates.
- Provide on-call availability, remote monitoring, weekend coverage, and some night coverage.
Basic Qualifications:
- Bachelor’s degree in a scientific discipline
- 2+ years of experience in a GMP environment
Preferred Qualifications:
- Working knowledge of quality systems (deviation, CAPA, change control, control documentation)
- Demonstrated ability to work in a collaborative environment
- Demonstrate GSK values and expectations (Patient Focus/Transparency/Respect/Integrity; Courage/Accountability/Development/Teamwork) in all interactions.
- Engage in cross-functional teams to prioritize improvements that simplify technical and business systems.
- Serve as a technical expert: understand production equipment/electronic systems and P&IDs; support quality processes (deviation, CAPA, change control).
- Own interactions between production and other departments to align needs with the manufacturing schedule.
- Follow safety procedures/training and escalate safety/compliance risks.
- Follow ALCOA principles for documentation; own deviation investigations, CAPA, impact assessments, and change controls; support auditor interactions.
- Schedule/track activities impacting manufacturing and documentation; manage raw materials/single-use component inventory; revise batch documents; use ERP; act as Lead Investigator.
- For NPI campaigns: train on and perform GMP operations (aseptic processing, cell culture, media/buffer prep, equipment prep, purification, final fill) and coach operators; may spend up to 80% in the production suite during campaigns.
- Identify/implement processing and quality system improvements and required documentation updates.
- Provide on-call availability, remote monitoring, weekend coverage, and some night coverage.
Basic Qualifications:
- Bachelor’s degree in a scientific discipline
- 2+ years of experience in a GMP environment
Preferred Qualifications:
- Working knowledge of quality systems (deviation, CAPA, change control, control documentation)
- Demonstrated ability to work in a collaborative environment