Quality Specialist II — GMP & Compliance

ThermoFisher Scientific; Franklin (MA); In loco; USD 67.000 - 101.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical & dental plans

Vision plan

PTO 120 hours

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Quality Specialist II in Massachusetts to ensure GMP compliance, FDA regulation adherence, and quality across manufacturing operations. You will lead investigations, drive continuous improvement, and maintain QMS under global healthcare initiatives.

Join a team that supports the mission to make the world healthier, safer, and cleaner, with collaboration across functions and opportunities for growth in a regulated environment.

Competenze

• Experience with cGMP, ISO 9001/13485 and regulatory requirements.
• Experience with TrackWise, MasterControl, Documentum or equivalent.
• Experience in deviation investigations, CAPA, change control, and root cause analysis.
• Proficient in Microsoft Office and quality management software systems.
• Technical writing and documentation skills.
• Analytical and problem-solving abilities.
• Clear verbal and written communication skills.
• Ability to work independently and collaboratively in cross-functional teams.
• Experience supporting internal audits and external regulatory inspections.
• Project management and organizational skills.
• Ability to work in warehouse environments and follow gowning procedures where required.
• Ability to work in a cold environment with exposure to dry ice and liquid nitrogen cryogenics.
• Must be able to process and handle materials frozen on dry ice or liquid nitrogen.
• Must use personal protective equipment and adhere to safety protocols.
• Up to 10% travel may be required.

Mansioni

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements.
• Support manufacturing operations across multiple product lines.
• Lead continuous improvement initiatives and investigations.
• Maintain quality management systems to enable corporate mission.
• Collaborate with cross-functional teams to drive quality across the organization.

Conoscenze

cGMP compliance

ISO 9001/13485

Quality systems

Root cause analysis

Analytical skills

Technical writing

Cross-functional teamwork

Audits & inspections

Project management

Gowning procedures

Cold environment

PPE adherence

Travel 10%

Formazione

Bachelor's degree in pharma/biotech

Life sciences background

Strumenti

TrackWise

MasterControl

Documentum

Quality management software (QMS)

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Quality Specialist II in Massachusetts to ensure GMP compliance, FDA regulation adherence, and quality across manufacturing operations. You will lead investigations, drive continuous improvement, and maintain QMS under global healthcare initiatives.

Join a team that supports the mission to make the world healthier, safer, and cleaner, with collaboration across functions and opportunities for growth in a regulated environment.