QC NPI QC Compliance & Documentation Specialist (Regular)

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Monza site is a hard-working pharmaceutical contract manufacturing and development facility. It focuses on aseptic injectable drugs and is increasingly dedicated to biologics. By joining a team of 1800+ colleagues, the chosen candidate will enjoy an outstanding, global, and fast-developing atmosphere. With revenue exceeding $24 billion and the industry’s largest investment in R&D, we empower our employees to make meaningful contributions to society.

MINIMUM REQUIREMENTS:

• High school diploma or degree in a scientific field is an advantage.
• Ability to work under critical timelines.
• Effective communication skills at all internal and external levels.
• Excellent attention to detail.
• Exceptional organizational skills.
  Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
  Join us

• Manage the documentation, reordering, and accurate storage of the Reference Standards and reagents of the DPS laboratory.
• Perform queries, with the frequency established by the procedures, to guarantee the availability of Std/Reagents from the DPS chemical laboratory.
• Ensure the resolution of problems with suppliers and those presented by analysts.
• Collaborate with the TLs of the DPS Chemical Laboratory to ensure the accurate management of Reference Standards and DPS laboratory reagents.
• Ensure documentation verification of standards/reagents for DPS Audits (Regulatory/Corporate and Customer Audits).
• Ensure successful regulatory and customer inspections by promptly responding to field requests and reviewing necessary documentation.
• Ensure the accurate and timely movement of the material, temporarily stored in the warehouse awaiting registration in the system, from the warehouse to the laboratory.
• Ensure verification of adherence to the Pharmacopoeias and evaluation in case of updates relating to the job performed.
• Update department-specific procedures.
• Ensure management of safety data sheet and carcinogenic reagent deadlines.
• Participate in updating the department’s SOPs at the request of the manager.
• Ensure that training packages are kept up to date with those assigned to the role.

EH&S:

• Understand emergency procedures and align with safe systems of work.
• Ensure compliance with environmental regulations.
• Promptly report any near misses and breaches of rules.