Specialist Quality Assurance

Title : Specialist Quality Assurance

Type: W2

Visa: USC/GC/EADS Preferred OPT/CPT (If they dont have any employer already) H1B (If open for H1B transfer)

• Provide quality onthefloor support of manufacturing reviewing documentation and providing realtime support of manufacturing issues changeovers etc.

• Support quality decisions that may impact operations ensuring appropriate escalation.

• Identify risks and communicate gaps for quality and GMP processes/systems.

• Reviews and approves facility alarms facility work order requests and returntoservice documentation.

• Supports reviews and approves Deviations and change controls

• Authors and reviews SOPs and policies to ensure compliance and adherence to regulations/cGMP operations.

• Collaborate with Manufacturing to resolve equipment and process issues

• Support internal audits.

• Practice safe work habits and adhere to Modernas safety procedures and guidelines.

Heres What Youll Bring to the Table:

• BS with 3 years of experience or a Masters level degree with at least 1 year of experience in the pharmaceutical/biotech industry.