Senior Manufacturing Lead – Biologics & GMP

CSL Plasma

Holly Springs (NC)

Sur place

USD 85 000 - 120 000

Plein temps

Il y a 10 jours

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Résumé du poste

Seqirus in Holly Springs, NC is seeking a Sr. Lead Associate to join our manufacturing operations team.

This on-site role focuses on leading a production group, ensuring high-quality biologics manufacturing while complying with cGMP standards and SOPs. You'll supervise daily activities, coordinate equipment and personnel, and collaborate with engineering, maintenance, automation, and QA to drive quality and efficiency in a state‑of‑the‑art facility in the fight against influenza and related

Qualifications

High School Diploma or equivalent vocational or technical education.
Expert knowledge of cGMP requirements.
Experience executing SOPs and documenting work.
5+ years' production experience.

Responsabilités

Hands-on production leadership for the team.
Assign activities across the team.
Assemble, set-up, and disassemble production equipment.
Complete process steps per SOPs and BPRs.
Document activities and review documentation per cGMPs.
Work with automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP).
Collaborate with engineering, maintenance, automation on project activities.
Coordinate Qualification and Validation activities.
Train team members to support team flexibility.
Coordinate equipment and personnel resources on daily basis.
Be point of contact and manage team when Supervisor is not present.
Collaborate with FLQA to resolve quality issues.
Support collection and tracking of area metrics and process control data.
Support complex investigations and CAPA completion for deviations.
Exhibit Seqirus Values and Behaviors.